| Trade Name | REPLY/ESPRIT PACEMAKERS |
| Generic Name | IMPLANTABLE RATE-RESPONSIVE CARDIAC PACEMAKER & PROGRAMMER |
| Applicant | SORIN CRM USA, INC. |
| PMA Number | P950029 |
| Recent Supplement Number | S072 |
| Contact | 2905 NORTHWEST BLVD SUITE 40 PLYMOUTH, MN, 55441 |
| Date Received | Oct 25, 2012 |
| Decision Date | Dec 11, 2012 |
| Product Code | NVZ |
| Advisory Committee | CV |
| Supplement Type | REAL-TIME PROCESS |
| Supplement Reason | |
| Expedited Review Granted? | N |
| Order Approval Statement | APPROVAL FOR A CHANGE TO THE QUARTZ CRYSTAL. |
| source | fda.gov |
| # | Decision Date | Reason/Type | Change |
|---|---|---|---|
| S071 | Aug 23, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF A CLEANING STEP AND NEW ELECTRICAL TEST EQUIPMENT. |
| S070 | Jul 31, 2012 | PROCESS CHANGE: PACKAGING/30-DAY NOTICE | UPDATE TO THE THERMOSEALING PROCESS. |
| S069 | Jul 30, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | MOVED COMPONENT ASSEMBLY STEP, REMOVAL OF AN OPTIONAL CLEANING STEP AND ALTERNATIVE COMPONENT ATTACHMENT INSPECTION EQUIPMENT. |
| S068 | Jun 11, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ALTERNATE MANUFACTURING EQUIPMENT. |
| S067 | Apr 19, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ALTERNATE METHOD FOR A HYBRID MODULE WIRE BONDING PROCESS. |
| S066 | Feb 16, 2012 | /30-DAY NOTICE | CLEAN ROOM LAYOUT MODIFICATIONS OF SALUGGIA, ITALY PLANT. |
| S065 | Feb 02, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITIONAL OVEN, AN UPDATED CLEANING PROCESS, AND AN UPDATE TO THE REWORK PROCESS. |
| S064 | Nov 23, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | IMPLEMENTATION OF AN ALTERNATE MANUFACTURING EQUIPMENT. |
| S062 | Sep 01, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | MODIFY THE PRE-CONDITIONING CYCLE BEFORE LASER WELDING AND THE USE OF AN ALTERNATE LASER SOURCE. |
| S061 | Aug 29, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO THE REFLOW SOLDERING PROFILE AND AN ALTERNATE TOOLING USED FOR THE PASSING OVEN. |
| S060 | Aug 18, 2011 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR THE ADDITION OF THE DPLUS AND ACCELERATION AND ATRIAL VENTRICULAR DELAY REDUCTION PACING MODES ALONG WITH MINOR SOFTWARE UPDATES. |
| S058 | Apr 08, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | UPDATE TO THE ELECTRONIC HYBRID MODULE CLEANING PROCESS. |
| S056 | Mar 22, 2011 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR A NEW SETSCREW AND TORQUE-LIMITING SCREWDRIVER ACCESSORY. |
| S057 | Mar 03, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | REMOVAL OF A HYBRID BAKING STEP, AND THE ADDITION OF A HYBRID CLEANING STEP. |
| S055 | Dec 15, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN THE REFLOW SOLDERING AND CLEANING PROCESS. |
| S054 | Aug 18, 2010 | PROCESS CHANGE - OTHER/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR ADDING A REINFORCED INSPECTION STEP TO THE MANUFACTURING PROCESS OF THE DEVICE. |
| S053 | Jun 28, 2010 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR PROGRAMMER SOFTWARE VERSION SMARTVIEW 2.20UG1 FOR USE WITH THE OVATION AND PARADYM ICDS AND CRT-DS AND THE REPLY AND ESPRIT PACEMAKERS. |
| S048 | Jun 18, 2010 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR SOFTWARE VERSIONS W1.5.2 AND W1.5.3 FOR THE REPLY PACEMAKER. |
| S049 | Jun 18, 2010 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR SOFTWARE VERSIONS W2.7.3 AND W2.7.4 FOR THE REPLY (V2) AND ESPRIT PACEMAKERS. |
| S052 | May 26, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN LOCATION OF THE HYBRID ELECTRONIC MODULE SUBCOMPONENT MANUFACTURING. |
| S051 | Mar 12, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGING FROM MANUAL TO AUTOMATED CLEANING PROCESS. |
| S050 | Feb 05, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN LOCATION OF THE HYBRID ELECTRONIC MODULE SUBCOMPONENT MANUFACTURING. |
| S047 | Oct 28, 2009 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN THE LOCATION FOR MANUFACTURING THE HYBRID ELECTRONIC MODULAR COMPONENT. |
| S045 | Sep 04, 2009 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO A VISUAL INSPECTION. |
| S046 | Jul 15, 2009 | PROCESS CHANGE - OTHER/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR THE ADDITION OF AN INSPECTION STEP TO CHECK FOR EXCESSIVE SILICONE ADHESIVE IN THE SET SCREW CAVITY. |
| S041 | Jun 11, 2009 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APPROVAL FOR THE ESPRIT MODELS SR AND DR PACEMAKER SYSTEMS WITH THE PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.16 UG1. |
| S044 | May 01, 2009 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | IMPROVEMENT IN MANUFACTURING BAL SEAL VERIFICATION. |
| S042 | Apr 02, 2009 | LABELING CHANGE - PERFORMANCE CHARACTERISTICS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR LABELING CHANGES TO THE REPLY DR AND REPLY SR IMPLANT MANUALS. |
| S043 | Apr 02, 2009 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN THE DRYING METHOD FOR THE HYBRID MODULE. |
| S040 | Feb 23, 2009 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN THE TYPE OF X-RAY MACHINE. |
| S039 | Feb 04, 2009 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR THE REPLY PACER EMBEDDED SOFTWARE W1.5.1 AND ASSOCIATED PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.10 UG1. |
| S038 | Oct 17, 2008 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE THE WELDING ENERGY MEASUREMENT METHOD FROM AN INDIRECT METHOD TO A DIRECT ENERGY MEASUREMENT METHOD. |
| S036 | Sep 10, 2008 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR THE PROGRAMMER APPLICATION SOFTWARE PACKAGE VERSION SMARTVIEW 2.02 UG4 FOR ORCHESTRA AND ORCHESTRA PLUS PROGRAMMERS. |
| S032 | Jul 25, 2008 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APPROVAL FOR REPLY SR/DR PACEMAKER MODELS AND SMARTVIEW 2.08UG1 PROGRAMMING SOFTWARE MANUFACTURED BY SORIN BIOMEDICA CRM, S.R.L., SALUGGIA (VC) ITALY. |
| S037 | Jul 23, 2008 | PROCESS CHANGE: MANUFACTURING/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR MANUFACTURING PROCESS CHANGES ENHANCING THE QUALITY CONTROLS PERTAINING TO SYMPHONY AND RHAPSODY PACEMAKERS AS WELL AS OVATIO ICD AND CRT-D SYSTEM DEVICES. |
| S034 | Mar 18, 2008 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR THE SMARTVIEW 2.02 UG3 SOFTWARE. THE SOFTWARE MODIFICATIONS ARE INTENDED TO MAKE MINOR SOFTWARE CORRECTIONS AND TO ADD THE PACEART XML CONVERTER TO THE SMARTVIEW 2.02 UG2 SOFTWARE. |
| S033 | Feb 13, 2008 | PROCESS CHANGE: MANUFACTURING/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR AN ADDITION INSPECTION STEP TO WEIGH THE FINAL DEVICE AFTER MANUFACTURING OF THE DEVICES. |
| S031 | Nov 13, 2007 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR THE SMARTVIEW 2.02 UG2 SOFTWARE AS WELL AS ASSOCIATED LABELING AND OPERATOR MANUAL UPDATES. THE SOFTWARE MODIFICATIONS ARE INTENDED TO MAKE MINOR SOFTWARE CORRECTIONS (MANAGER, OVATION) AND TO INCLUDE A DOWNLOADABLE RAM PATCH (SYMPHONY/ RHAPSODY). |
| S030 | Jun 29, 2007 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/NORMAL 180 DAY TRACK | APPROVAL FOR THE ORCHESTRA PLUS PROGRAMMER AND ELAVIEW 2.02 PROGRAMMING SOFTWARE. |
| S029 | Sep 22, 2006 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR A COUNTERBORE BEING ADDED TO THE CERAMIC INSULATOR TO ACCOMMODATE THE BRAZED GOLD FOR EACH FEEDTHROUGH WIRE. |
| S027 | Sep 15, 2006 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN THE FLUX USED FOR SOLDER REWORK. |
| S028 | Sep 15, 2006 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE FROM CLEANING WITH THE KERRY MACHINE TO CLEANING WITH THE MBTECH MACHINE, AND THE ADDITION OF AN MBTECH CLEANING STEP AND VISUAL INSPECTION STEP. |
| S026 | Jul 26, 2006 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR THE ELAVIEW 1.34 UGI PROGRAMMING SOFTWARE. |
| S025 | Mar 15, 2006 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR THE HARDWARE MODIFICATION OF THE CPR3 PROGRAMMING HEAD TO BE USED WITH ALL THE ELA?S ICD AND PACEMAKER SYSTEMS. |
| S024 | Sep 02, 2005 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR THE FOLLOWING SOFTWARE UPDATES: 1) AAISAFER RAM PATCH 2.3 FOR SYMPHONY DR 2550 DEVICES WITH ROM MASK T3, 2) ROM MASK T4 FOR SYMPHONY DR 2550, SYMPHONY SR 2250, ELA RHAPSODY+ DR 2530, ELA RHAPSODY DR 2510, AND ELA RHAPSODY SR 2210, 3) ELAVIEW 1.30 UG2 APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER. |
| S022 | Apr 27, 2005 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SPECIFICATIONS/NORMAL 180 DAY TRACK | APPROVAL FOR THE AAISAFER2 PACING MODE AND THE ELAVIEW 1.28 UG1 PROGRAMMING SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SYMPHONY DR 2550 AND IS INDICATED FOR: 1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION AND/OR ACTIVITY. 2) THE ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE, BUT ARE NOT RESTRICTED TO: SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREE AV BLOCK, SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK, SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS, BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS AND VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES. IN ADDITION, THE DUAL-CHAMBER AND ATRIAL TRACKING MODES IS INDICATED FOR PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY. DUAL-CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY WHICH INCLUDE: VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT AND VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM. |
| S023 | Feb 28, 2005 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN STERILIZATION PROCESS PARAMETERS. |
| S021 | Oct 27, 2004 | LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK) | APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE SYMPHONY AND ELA RHAPSODY PACEMAKERS TO INCLUDE INSTRUCTIONS ABOUT TESTING, SENSING OR PACING WHILE THE PACEMAKER IS OUT OF THE POCKET. |
| S020 | Jul 15, 2004 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - MATERIAL/REAL-TIME PROCESS | APPROVAL FOR UNCOATED VERSIONS OF THE SYMPHONY AND ELA RHAPSODY PACEMAKERS. |
| S019 | Feb 13, 2004 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR THE FIRMWARE MODIFICATIONS (VERSION GXD T3) OF THE SYMPHONY AND ELA RHAPSODY PACEMAKERS. |
| S017 | Oct 24, 2003 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APPROVAL FOR NEW PACEMAKER MODELS, SYMPHONY MODELS 2550, AND 2250 AND ELA RHAPSODY MODELS 2530, 2510 AND 2210. THE SYMPHONY AND ELA RHAPSODY PACEMAKER SYSTEMS ARE INDICATED FOR: 1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION AND/OR ACTIVITY. 2) THE ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE, BUT ARE NOT RESTRICTED TO: A) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND- OR THIRD-DEGREE AV BLOCK; B) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK; C) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS: D) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS; E) VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES. IN ADDITION, THE DUAL-CHAMBER AND ATRIAL TRACKING MODES (SYMPOHONY DR MODEL 2550 AND ELA RHAPSODY DR MODELS 2530 AND 2510) ARE INDICATED FOR PATITNES WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY. DUAL-CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY WHICH INCLUDE: 1) VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT; AND 2) VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM. |
| S016 | Dec 18, 2002 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APPROVAL FOR THE ADDITION OF THE AUTOSENSING FEATURE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TALENT II, MODELS DR233 AND SR133, AND IS INDICATED FOR RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION AND/OR ACTIVITY. THE ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING INCLUDE: 1) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD DEGREE AV BLOCK; 2) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK; 3) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS; 4) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS; 5) VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES. THE MODEL DR233 IS ALSO INDICATED FOR DUAL-CHAMBER AND ATRIAL TRACKING MODES IN PATIENTS WHOM MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY. DUAL-CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY, WHICH INCLUDE: 1) VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT; 2) VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM. |
| S015 | Nov 26, 2001 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL TO CHANGE THE SILICONE HEADER CURRENTLY IN USE WITH THE SINGLE CHAMBER TALENT AND BRIO DEVICES TO TECOTHANE 75D POLYURETHANE HEADER (RIGID HEADER). |
| S014 | Jul 03, 2001 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APPROVAL FOR THE AUTOTHRESHOLD FEATURE ON TWO TALENT MODEL PACEMAKERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TALENT MODELS DR233 AND SR133 AND IS INDICATED FOR THE FOLLOWING: RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION AND/OR ACTIVITY. THE ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: 1) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREE AV BLOCK; 2) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK; 3) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS; 4) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS; 5) VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES. DUAL-CHAMBER AND ATRIAL TRACKING MODES IN PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY. DUAL-CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY WHICH INCLUDE: 1) VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT; 2) VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM. |
| S013 | Feb 02, 2001 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR A NEW DIGITAL PACING CHIP, THE LOGAUTO H5, BRIO AND TALENT FIRMWARE MASK L4, AND CSO VERSION 4.16UG PROGRAMMER SOFTWARE. |
| S011 | Oct 11, 2000 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL IS FOR THE FOLLOWING MODIFICATIONS TO YOUR BRIO FAMILY OF PACEMAKERS: 1) MODIFY THE VALUE FOR THE NUMBER OF CYCLES THE DEVICE WILL ALLOW BEFORE A SELF TEST IS INITIATED WHEN THE SENSOR "CALLS FOR AN ELEVATED PACING RATE FOR A DURATION OR FREQUENCY THAT EXCEES REASONABLE PHYSIOLOGIC LIMITS" FROM 30,000 TO 100,000 CYCLES; AND 2) CHANGING THE MINIMUM SENSING THRESHOLD DURING T-WAVE PROTECTION FROM 2.2 TO 2.5MV. |
| S010 | Oct 10, 2000 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - MATERIAL/REAL-TIME PROCESS | APPROVAL TO CHANGE THE HEADER MATERIAL IN THE TALENT AND BRIO PACEMAKERS FROM SILICONE RUBBER TO TECOTHANE 75D POLYURETHANE |
| S012 | Sep 13, 2000 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR CHANGES TO THE IMPLANT AND PROGRAMMER SOFTWARE FOR THE TALENT AND BRIO FAMILIES OF PACEMAKERS. |
| S006 | May 18, 2000 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | Approval for the introduction of Talent Rate Responsive Pacemaker Models DR213, DR223, and SR113; the Optus G Rate Responsive Pacemaker Models 4621 and 4624; and the CSO 4.12 Programming Software. |
| S008 | Dec 03, 1999 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/NORMAL 180 DAY TRACK | Approval for the Multi-Partition Operating Environment to be used on ELA Medical programmers. |
| S009 | Nov 19, 1999 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | Approval for the CSO 4.10 UG Programmer Software, for use with the ELA programmers. |
| S007 | Sep 16, 1999 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | Approval for the introduction of version 5 of the Brio pacemakers, including the introudction ofthe dedicated bipolar Model 222. |
| S005 | Aug 25, 1999 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/NORMAL 180 DAY TRACK | Approval for access to programmable rest-rate and non-invasive physiological stimulation (NIPS) parameters. The device is indicated for dual-chamber cardiac pacing with the ability to perform limited non-invasive electrophysiological studies. |
| S001 | Dec 22, 1998 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | Approval for functional changes to reduce size and update algorithms and features in previously approved Chorus RM Model 7034 and Opus RM Model 4534. The device, as modified, will be marketed under the trade name Brio and is indicated for: The generally accepted patient conditions warranting chronic cardiac pacing which include: 1) Symptomatic paroxysmal or permanent second or third-degree AV block; 2) Symptomatic bilateral bundle branch block; 3) Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conductions disorders; 4) Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomaitc tachyarrhythmias; and 5) Vaso-vagal syndrome or hypersensitive carotid sinus syndromes. The Brio is also indicated for dual-chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual-chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony which include: 1) Various degrees of AV block to maintain the atrial contribution to cardiac output; and 2) VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm. |
| S003 | Nov 18, 1998 | LOCATION CHANGE: STERILIZER/NORMAL 180 DAY TRACK | Approval for a sterilization site located at Griffith MicroScience S.A., 8 rue Parmentier, 60290 Rantigny, France. |
| S002 | Oct 09, 1998 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | Approval for the new Model CPR1D Programmer Head. |
| Mar 10, 1997 | Original Approval | APPROVAL FOR THE CHORUS RM MODEL 7034 DDDR PACEMAKER SYSTEM AND OPUS RM MODEL 4534 SSIR PACEMAKER SYSTEM WHICH INCLUDES AN IBM COMPATIBLE MICROCOMPUTER WHICH HAS BEEN CONFIGURED AND FURNISHED BY ELA MEDICAL, INC. WITH CSO 2.46 PROGRAMMING SOFTWARE AND IS CONNECTED TO A CPR1 PROGRAMMING HEAD. THESE DEVICES ARE INDICATED FOR: RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION; AND THE GENERALLY ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: *SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREEE AV BLOCK; *SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK; *SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS; *BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS; AND *VASO-VAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES. THE CHROUS RM IS ALSO INDICATED FOR DUAL-CHAMBER AND ATRIAL TRACKING MODES IN PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY. DUAL-CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY WHICH INCLUDE: *VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT; AND *VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM. |