SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System and SYNERGY SHIELD Everolimus Eluting Platinum Chr
FDA premarket approval P150003/S100 · decided 2024-12-18
Approval details
- PMA number
- P150003
- Supplement
- S100
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System and SYNERGY SHIELD Everolimus Eluting Platinum Chr
- Generic name
- Coronary drug-eluting stent
- Applicant
- Boston Scientific Corporation
- Date received
- 2024-06-21
- Decision date
- 2024-12-18
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- updated labeling to include a new section that summarizes the results of the post approval study design, results and study strengths and limitations for the EVOLVE 4.5/5.0 PAS
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