SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Co
FDA premarket approval P150003/S096 · decided 2024-01-19
Approval details
- PMA number
- P150003
- Supplement
- S096
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Co
- Generic name
- Coronary drug-eluting stent
- Applicant
- Boston Scientific Corporation
- Date received
- 2023-06-29
- Decision date
- 2024-01-19
- Days to decision
- 204 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval of introduction of the S756 Ethylene Oxide (EtO) sterilization cycle at Synergy Sterilization (M) Sdn Bhd1 located in Kuala Ketil, Malaysia
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