| Trade Name | PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM |
| Generic Name | |
| Applicant | BOSTON SCIENTIFIC CORPORATION |
| PMA Number | P110010 |
| Recent Supplement Number | S046 |
| Contact | ONE SCIMED PLACE MAPLE GROVE, MN, 55311 |
| Date Received | Jan 25, 2013 |
| Decision Date | Feb 21, 2013 |
| Product Code | NIQ |
| Advisory Committee | CV |
| Supplement Type | 30-DAY NOTICE |
| Supplement Reason | PROCESS CHANGE: MANUFACTURING |
| Expedited Review Granted? | N |
| Order Approval Statement | ADDITION OF SOFTWARE CONTROLS TO THE SECONDARY PACK SEALER. |
| source | fda.gov |
| # | Decision Date | Reason/Type | Change |
|---|---|---|---|
| S047 | Feb 21, 2013 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | SOFTWARE AND HARDWARE UPGRADES TO THE INTEGRATED CRIMP AND CONE PUFF MACHINES. |
| S045 | Feb 14, 2013 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | USE OF AN ALTERNATE IN-PROCESS INSPECTION. |
| S044 | Jan 30, 2013 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | REDUCTION IN SAMPLE SIZE USING ANALYTICAL CHEMISTRY METHODS FOR IDENTIFYING EVEROLIMUS, AND FOR DETERMINING DEGRADATION AND IMPURITIES. |
| S018 | Jan 29, 2013 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR AN UPDATE TO THE DISTAL WELD INSPECTION CRITERIA FOR ACCEPTABLE BUBBLE SIZE. |
| S043 | Jan 08, 2013 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | TWO SOFTWARE UPDATES TO THE MIDSHAFT HOT JAW BONDING PROCESS. |
| S026 | Dec 21, 2012 | DESIGN CHANGE - MINOR/REAL-TIME PROCESS | APPROVAL FOR A CHANGE TO THE BODY LENGTH OF THE DELIVERY SYSTEM BALLOON. |
| S042 | Dec 21, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CONSOLIDATE MEASUREMENT AND INSPECTION STEPS ONTO THE SAME MANUFACTURING LINE. |
| S041 | Dec 19, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | SOFTWARE MODIFICATIONS TO THE BALLOON MANUFACTURING EQUIPMENT. |
| S039 | Dec 13, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO THE ANNEALING TEMPERATURES FOR DELIVERY CATHETERS. |
| S038 | Dec 11, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | REMOVAL OF TWO IN-PROCESS INSPECTIONS. |
| S040 | Dec 11, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | USE OF AN ELECTRONIC RECORDS SYSTEM. |
| S034 | Nov 29, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | MODIFICATION OF THE DISTAL HEAT SHRINK ALIGNMENT SOFTWARE. |
| S033 | Nov 23, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF A SECOND INJECTION MOLDING LINE FOR MANIFOLD-HYPOTUBE ASSEMBLIES. |
| S036 | Nov 23, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | UPDATES TO THE VISUAL STANDARD INSPECTION CRITERIA FOR GOUGES. |
| S037 | Nov 23, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | SOFTWARE UPGRADE TO THE VISICON INSPECTION SYSTEM. |
| S032 | Nov 20, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGES TO PROXIMAL BALLOON BOND MANUFACTURING SOFTWARE. |
| S031 | Nov 05, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | MANUFACTURING SOFTWARE CHANGES PERTAINING TO THE CATHETERS. |
| S030 | Oct 24, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGES TO WELD AND HEAT SHRINK REMOVAL PROCESS PARAMETERS. |
| S028 | Sep 27, 2012 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/REAL-TIME PROCESS | APPROVAL FOR REMOVAL OF THE BALL FROM THE TIP OF THE COREWIRE WHICH IS LOCATED BETWEEN THE INNER AND OUTER LUMEN OF THE STENT DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM AND ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM AND ARE INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE OR DOCUMENTED SILENT ISCHEMIA DUE TO DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH, AND FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >2.25 MM TO <4.00 MM IN DIAMETER IN LESIONS <34 MM IN LENGTH, RESPECTIVELY |
| S029 | Sep 21, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE. |
| S024 | Sep 17, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGES TO THE DISTAL BOND PROCESS FOR THE STENT DELIVERY SYSTEM. |
| S027 | Sep 06, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE. |
| S020 | Aug 24, 2012 | POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL OF THE POST-APROVAL STUDY PROTOCOL. |
| S021 | Aug 23, 2012 | POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |
| S010 | Aug 16, 2012 | /135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR HARDWARE AND SOFTWARE CHANGES TO THE CATHETER PORT MANUFACTURING PROCESS. |
| S025 | Aug 14, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGES TO THE INSPECTION MANDREL VERIFICATION PROCESS. |
| S023 | Jul 27, 2012 | PROCESS CHANGE - OTHER/30-DAY NOTICE | ADDITION OF THE LISTED DEVICES TO THE APPROVED LIST OF PMAS PROCESSED BY A CONTRACT STERILIZER.. |
| S022 | Jul 26, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | SOFTWARE MODIFICATION TO THE BALLOON STRETCHING PROCESS. |
| S019 | Jul 20, 2012 | PROCESS CHANGE: STERILIZATION/30-DAY NOTICE | SOFTWARE AND HARDWARE CHANGES TO THE ETHYLENE OXIDE STERILIZATION CHAMBER 1. |
| S016 | Jul 11, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | PERFORM MANUAL MEASUREMENT OF THE PROXIMAL BALLOON BOND. |
| S017 | Jul 11, 2012 | /30-DAY NOTICE | CHANGE TO THE LOCATION OF A CRITICAL COMPONENT SUPPLIER. |
| S015 | Jul 06, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF NEW SOFTWARE TO INTERFACE WITH THE MANUFACTURING EXECUTION SYSTEM (MES). |
| S001 | Jun 01, 2012 | CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/PANEL TRACK | APPROVAL FOR THE PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE). THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE OR DOCUMENTED SILENT ISCHEMIA DUE TO DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH. |
| S014 | May 30, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | REMOVAL OF WAIST LENGTH IN-PROCESS INSPECTION STEPS. |
| S004 | May 11, 2012 | POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL/NORMAL 180 DAY TRACK NO USER FEE | APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |
| S006 | May 10, 2012 | Original Approval | APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |
| S011 | Apr 19, 2012 | PROCESS CHANGE: STERILIZATION/30-DAY NOTICE | IMPLEMENTATION OF AN EXISTING PROCESS TO AN EXISTING STERILIZATION EQUIPMENT. |
| S009 | Apr 13, 2012 | /30-DAY NOTICE | ALTERNATIVE PROCESS FOR THE MANUFACTURING OF CATHETER ASSEMBLIES. |
| S012 | Apr 13, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | IMPLEMENTATION OF A NEW LASER SYSTEM FOR SORTING EXTRUDED BALLOON TUBES. |
| S005 | Apr 05, 2012 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR VARIOUS CYCLE TIME REDUCTIONS. |
| S008 | Apr 03, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | MANUFACTURING EQUIPMENT CHANGE FOR THE DRUG SPRAYING PROCESS. |
| S007 | Mar 09, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | ADDITION OF A CATHETER MANIFOLD MOLDING LINE AT THE GALWAY MANUFACTURING FACILITY. |
| S003 | Jan 13, 2012 | PROCESS CHANGE: STERILIZATION/30-DAY NOTICE | SOFTWARE AND EQUIPMENT HARDWARE UPDATES TO A STERILIZATION CHAMBER AT THE COVENTRY, RHODE ISLAND FACILITY. |
| S002 | Dec 14, 2011 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | UPDATE TO THE PORT WELD HEAT SHRINK REMOVAL PROCESS. |
| Nov 22, 2011 | Original Approval | APPROVAL FOR THE PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=28 MM IN LENGTH. |