SYNERGY SHIELD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chrom
FDA premarket approval P150003/S098 · decided 2023-10-17
Approval details
- PMA number
- P150003
- Supplement
- S098
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNERGY SHIELD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chrom
- Generic name
- Coronary drug-eluting stent
- Applicant
- Boston Scientific Corporation
- Date received
- 2023-09-14
- Decision date
- 2023-10-17
- Days to decision
- 33 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- addition of an imaging based system for automating the coating patch process
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