SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System
FDA premarket approval P150003/S054 · decided 2021-01-22
Approval details
- PMA number
- P150003
- Supplement
- S054
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Boston Scientific Corporation
- Date received
- 2019-09-03
- Decision date
- 2021-01-22
- Days to decision
- 507 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- 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.
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