|
Device | SYNERGY 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 | S039 |
Date Received | 03/09/2018 |
Decision Date | 10/18/2018 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for 4.50 mm and 5.00 mm diameter device sizes |
Post-Approval Study | Show Report Schedule and Study Progress |