|
Device | Synergy Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System |
Generic Name | Coronary drug-eluting stent |
Applicant | BOSTON SCIENTIFIC CORPORATION One Scimed Place Maple Grove, MN 55311 |
PMA Number | P150003 |
Supplement Number | S044 |
Date Received | 11/14/2018 |
Decision Date | 12/14/2018 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Reduction in the number of samples used for batch release and annual stability testing for the 4.50 and 5.00 mm stents. |