SYNERGY, SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System
FDA premarket approval P150003/S083 · decided 2022-02-10
Approval details
- PMA number
- P150003
- Supplement
- S083
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNERGY, SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Boston Scientific Corporation
- Date received
- 2022-01-20
- Decision date
- 2022-02-10
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Addition of an alternative contract testing laboratory to carry out confirmatory testing on Everolimus for the SYNERGY and PROMUS devices.
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