|
Device | SYNERGY MEGATRON 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 | S054 |
Date Received | 09/03/2019 |
Decision Date | 01/22/2021 |
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 a new stent design for the 3.50 to 5.00 mm sizes along with modifications to the expansion balloon and manifold. |