| Trade Name | ELCA CORONARY ATHERECTOMY CATHETERS |
| Generic Name | CORONARY ANGIOPLASTY CATHETER |
| Applicant | SPECTRANETICS CORP. |
| PMA Number | P910001 |
| Recent Supplement Number | S064 |
| Contact | 9965 FEDERAL DRIVE COLORADO SPRINGS, CO, 80921 |
| Date Received | Jan 31, 2013 |
| Decision Date | Feb 28, 2013 |
| Product Code | LPC |
| Advisory Committee | CV |
| Supplement Type | 30-DAY NOTICE |
| Supplement Reason | PROCESS CHANGE: MANUFACTURING |
| Expedited Review Granted? | N |
| Order Approval Statement | CHANGE TO THE PROCESS FOR MONITORING THE ETHYLENE OXIDE STERILIZATION PROCESS. |
| source | fda.gov |
| # | Decision Date | Reason/Type | Change |
|---|---|---|---|
| S063 | Jan 08, 2013 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ALTERNATE SUPPLIER FOR CABLE ASSEMBLIES. |
| S062 | Dec 26, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF A NEW COMPUTER NUMERIC CONTROL (CNC) MACHINING TOOL. |
| S061 | Sep 05, 2012 | PROCESS CHANGE: STERILIZATION/30-DAY NOTICE | USE OF ADDITIONAL STERILIZATION CHAMBERS AT THE CONTRACT STERILIZER. |
| S060 | Jul 31, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGES TO THE ON-DEMAND LABEL PRINTING SYSTEM. |
| S058 | Jul 25, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF NEW EXTRUSION EQUIPMENT. |
| S057 | Jul 06, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF A COMPONENT SUPPLIER FOR THE DEVICE. |
| S056 | Jul 03, 2012 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR A CHANGE TO THE RADIO FREQUENCY (RF) ABSORPTION MATERIAL FOR THE CVX-300P MODEL EXCIMER LASER. |
| S055 | May 30, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | AUTOMATION OF LOT NUMBER ASSIGNMENT FOR PRINTING. |
| S054 | May 02, 2012 | PROCESS CHANGE: STERILIZATION/30-DAY NOTICE | MODIFICATION TO THE ETHYLENE OXIDE STERILIZATION CYCLE. |
| S053 | Feb 24, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | REMOVE REDUNDANT QUALITY CONTROL INSPECTION STEPS IN YOUR FIBER DRAW AND FIBER RE-SPOOLING MANUFACTURING PROCESSES. |
| S051 | Feb 17, 2012 | PROCESS CHANGE: STERILIZATION/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR THE USE OF A NEW STERILIZATION CHAMBER, NEW STERILIZATION CYCLE, CHANGE IN PACKAGING CONFIGURATION FOR STERILIZATION, AND A CHANGE IN THE STERILE LOAD CONFIGURATION. |
| S047 | Jan 13, 2012 | LOCATION CHANGE: MANUFACTURER/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL FOR A MANUFACTURING SITE LOCATED IN COLORADO SPRINGS, COLORADO. |
| S052 | Dec 27, 2011 | PROCESS CHANGE: STERILIZATION/30-DAY NOTICE | CHANGE IN EO STERILIZATION PROCESS MONITORING. |
| S050 | Dec 06, 2011 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL TO IMPLEMENT A CHANGE TO THE RADIO FREQUENCY (RF) ABSORPTION MATERIALS FOR THE CVX-300P MODEL EXCIMER LASER. |
| S040 | Nov 18, 2011 | LOCATION CHANGE: STERILIZER/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL FOR A STERILIZATION SITE LOCATED AT CARIDIANBCT STERILIZATION SERVICES IN LAKEWOOD, COLORADO. |
| S049 | Oct 25, 2011 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/REAL-TIME PROCESS | APPROVAL FOR SOFTWARE CHANGES TO THE CVX-300 AND CVX-300-P LASER SYSTEMS. |
| S045 | Jul 14, 2011 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR CHANGES TO PYROGEN TESTING PROCEDURES AND SAMPLING. |
| S048 | Jun 08, 2011 | /30-DAY NOTICE | ADDITION OF AN ALTERNATE SUPPLIER FOR A DEVICE COMPONENT. |
| S042 | Apr 20, 2011 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL TO IMPLEMENT THE USE OF AN AUTOMATED METHOD INSTEAD OF A MANUAL METHOD OF DISPENSING EPOXY ADHESIVE. |
| S044 | Feb 28, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | MODIFICATIONS TO THE GLASS PREFORM PROCESS. |
| S043 | Feb 03, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | USE OF ADDITIONAL POUCH SEALING EQUIPMENT. |
| S034 | Jan 10, 2011 | LOCATION CHANGE: MANUFACTURER/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL FOR A MANUFACTURING SITE LOCATED IN COLORADO SPRINGS, COLORADO. |
| S041 | Dec 29, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE IN PROCESSING EQUIPMENT FROM HAND-ACTIVATED TO FOOT-ACTIVATED. |
| S038 | Nov 10, 2010 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF AN ALTERNATE DI WATER SUPPLY. |
| S037 | Oct 15, 2010 | PROCESS CHANGE - OTHER/30-DAY NOTICE | CHANGE TO THE LABEL PRINTING PROCESS. |
| S033 | Jul 08, 2010 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | APPROVAL FOR CHANGES TO THE CVX-300 EXCIMER LASER SYSTEM FOR COMPLIANCE TO ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY VOLUNTARY STANDARDS. |
| S032 | Jul 29, 2009 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - MATERIAL/REAL-TIME PROCESS | APPROVAL FOR A CHANGE IN THE MATERIAL OF THE PROXIMAL COUPLER COMPONENT OF THE ELCA CATHETERS. |
| S031 | Jun 01, 2009 | PROCESS CHANGE: PACKAGING/30-DAY NOTICE | CHANGES TO THE IN-PROCESS ACCEPTANCE ACTIVITIES FOR THE LABELING AND BOXING PROCESS. |
| S027 | Mar 25, 2009 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR: 1) REMOVAL OF BIOBURDEN TESTING FROM THE LOT HISTORY RECORDS (LHR) AS A TEST REQUIRED FOR RELEASE OF PRODUCT, AND 2) CHANGE LAL ENDOTOXIN TEST PROCEDURE TO INSTRUCT QUALITY ASSOCIATES TO COLLECT PRODUCT SAMPLE POST-STERILIZATION. |
| S028 | Dec 11, 2008 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO AN IN-PROCESS MANUFACTURING AID. |
| S026 | May 11, 2007 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | APPROVAL FOR THE REMOVAL OF A COATING ON THE INNER LUMEN OF THE EXTREME CATHETER MODEL NUMBERS 114-001, 117-002, AND 120-001, THE CHANGE TO BLACK TUBING FOR 0.9 MM CATHETER MODEL NUMBERS 110-003 AND 110-004 X-80, AND THE CHANGE IN THE STRAIN RELIEF MATERIAL DUROMETER FOR THE 0.9 MM EXTREME CATHETER MODEL NUMBERS 110-001, 110-002, 110-152 AND 0.7 MM EXTREME CATHETER MODEL 110-005 TO PREVENT KINKING AT THE STRAIN RELIEF. |
| S025 | Aug 02, 2006 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/REAL-TIME PROCESS | APPROVAL FOR A NEW SOFTWARE VERSION TO THE CVX-3000 EXCIMER LASER AND REVISED LABELING TO THE LASER CONSOLE. |
| S024 | Aug 08, 2003 | LABELING CHANGE - INSTRUCTIONS/NORMAL 180 DAY TRACK | APPROVAL FOR CHANGES TO INSTRUCTIONS FOR USE, INCLUDING CHANGES TO THE CONTRAINDICATIONS SECTION, FOR THE VITESSE COS RX, VITESSE E, AND EXTREME OTW CATHETERS. |
| S023 | May 02, 2003 | LABELING CHANGE - MINOR/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL FOR THE REVISED INSTRUCTIONS FOR USE THAT INCLUDE THE ADJUDICATED RESULTS FROM THE LARS INVESTIGATION. |
| S021 | Feb 04, 2003 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APPROVAL FOR THE 0.7 MM SIZE OF THE EXTREME OTW X80 PERCUTANEOUS EXCIMER LASER CORONARY ANGIOPLASTY CATHETER. |
| S020 | Oct 10, 2001 | LABELING CHANGE - INDICATIONS/NORMAL 180 DAY TRACK | APPROVAL FOR AN ADDITIONAL INDICATION, THE TREATMENT OF RESTENOSIS IN 316L STAINLESS STEEL STENTS, PRIOR TO THE ADMINISTRATION OF INTRAVASCULAR BRACHYTHERAPY, FOR THE CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM. THE INDICATION IS IN ADDITION TO THOSE LISTED IN THE FEBRUARY 19, 1993, APPROVAL LETTER. |
| S019 | Jun 19, 2001 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SPECIFICATIONS/NORMAL 180 DAY TRACK | VITESSE POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODEL 110-004, AND THE EXTREME POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODEL 110-002: 1) A CHANGE IN THE LASTING TIME FROM 5 SECONDS ON AND 10 SECONDS OFF TO 10 SECONDS ON AND 5 SECONDS OFF; 2) A CHANGE IN THE FLUENCE AND REPETITION RATE FROM 30-60 FLUENCE AND 25-40 HZ TO 30-80 FLUENCE AND 25-80 HZ; 3) A LABELING CHANGE FROM "LASER ADVANCEMENT OF APPROXIMATELY 1 MM PER SECOND" TO "MAINTAIN CONSTANT CATHETER TIP CONTACT WITH THE LESION BY APPLYING MILD FORWARD PRESSURE TO THE SHAFT OF THE CATHETER"; AND 4) A CHANGE IN THE PIN CODE ON THE COUPLER SO THAT THE CATHETERS INSTRUCT THE LASER SYSTEM TO ALLOW INCREASED LASING PARAMETERS. |
| S018 | Aug 04, 2000 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | APPROVAL FOR THE VITESSE XTO 0.9 MM CORONARY ANGIOPLASTY CATHETER, MODEL 110-003. |
| S015 | Jul 11, 2000 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | APPROVAL FOR THE EXTREME 0.9 MM CORONARY ANGIOPLASTY CATHETER. |
| S017 | Mar 17, 2000 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | The 135-day supplement requested approval for the addition of ethylene oxide sterilization equipment. |
| S014 | Jan 28, 2000 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACK | Approval is for the Vitesse-C OS Laser Angioplasty Cathethers, Models 114-009, 117-016, and 120-009. |
| S016 | Dec 10, 1999 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/NORMAL 180 DAY TRACK | Approval for software modifications for the Power Error audible tone warning and Fault 10 display features. |
| S013 | Mar 12, 1999 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/NORMAL 180 DAY TRACK | Approval for Software Versions 3.51 and 3.6. |
| S012 | Sep 24, 1997 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | Approval for the 2.0 mm Vitesse(TM)-EII (Eccentric Monorail) Catheter, Model 120-008. |
| S005 | Jul 31, 1995 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | APPROVAL FOR VITESSE-E (MODEL 117-005) & VITESSE-E II (MODEL 117-205) CATHETERS TO BE USED WITH THE CVX-300 EXCIMER LASER SYSTEM ON ECCENTRIC LESIONS MEETING ONE OR MORE OF YOUR APPROVED INDICATIONS FOR USE |
| S008 | Jul 12, 1995 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE/NORMAL 180 DAY TRACK | APPROVAL FOR UPGRADED SOFTWARE (VERSION 3.4) FOR THE SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM |
| S010 | May 16, 1995 | LOCATION CHANGE - OTHER/NORMAL 180 DAY TRACK | |
| S009 | Mar 24, 1995 | OTHER/NORMAL 180 DAY TRACK | |
| S007 | Nov 15, 1994 | LABELING CHANGE - OTHER/NORMAL 180 DAY TRACK | |
| S006 | Oct 31, 1994 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | |
| S001 | Oct 18, 1993 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | |
| S002 | Sep 23, 1993 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/NORMAL 180 DAY TRACK | |
| Feb 19, 1993 | Original Approval | APPROVAL FOR THE SPECTRANETICS CVX-300(TM) EXCIMER LASER SYSTEM, INCLUDING THE MODELS PC1014 AND PC1017 LASER CATHETERS. THIS SYSTEM IS INDICATED FOR USE IN PATIENTS WITH SINGLE OR MULTIVESSEL CORONARY ARTERY DISEASE EITHER AS A STAND ALONE MODALITY OR IN CONJUNCTION WITH PERCUTANEOUS TRANSLUMINAL CORONARY BALLOON ANGIOPLASTY (PTCA) AND WHO ARE ACCEPTABLE CANDIDATES FOR CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. ADJUNCTIVE BALLOON ANGIOPLASTY WAS PERFORMED, AT THE CLINICAL INVESTIGATOR'S DISCRETION, IN 84 PERCENT OF THE LESIONS TREATED. CLINICAL EXPERIENCE HAS PROVIDED REASONABLE ASSURANCE THAT THE SPECTRANETICICS CVX-300(TM) EXCIMER LASER SYSTEM AND MULTIFIBER LASER CATHETERS ARE SAFE AND EFFECTIVE FOR THE FOLLOWING INDICATIONS:OCCLUDED SAPHENOUS VEIN BYPASS GRAFTS; OSTIAL LESIONS; LONG LESIONS (GREATER THAN 20 MM IN LENGTH); MODERATELY CALCIFIED STENOSES (HEAVILY CALCIFIED STENOSES ARE THOSE LESIONS THAT DEMONSTRATE COMPLETE CALCIFICATION WHEN IDENTIFIED UNDER FLUOROSCOPY PRIOR TO THE PROCEDURE. MODERATELY AND SLIGHTLY CALCIFIED STENOSES ARE ALL OTHERS.); TOTAL OCCLUSIONS TRAVERSABLE BY A GUIDEWIRE; AND LESIONS WHICH HAVE PREVIOUSLY FAILED BALLOON ANGIOPLASTY (THIS INCLUDES THOSE LESIONS THAT WERE TREATED UNSUCCESSFULLY BY PTCA. LESIONS THAT HAVE UNDERGONE A COMPLICATED PTCA PROCEDURE ARE NOT INCLUDED IN THIS CATEGORY.) THESE LESIONS MUST BE TRAVERSABLE BY A GUIDEWIRE AND COMPOSED OF ATHERSCLEROTIC PLAQUE AND/OR CALCIFIED MATERIAL. THE LESIONS SHOULD BE WELL DEFINED BY ANGIOGRAPHY. |