|
Device | SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MO & OTW |
Generic Name | Coronary drug-eluting stent |
Applicant | BOSTON SCIENTIFIC CORPORATION One Scimed Place Maple Grove, MN 55311 |
PMA Number | P150003 |
Supplement Number | S015 |
Date Received | 07/15/2016 |
Decision Date | 12/07/2016 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval to consolidate the Final Inspect operation performed at the end of Stent Delivery Catheter (SDC) manufacturing process. |