Synergy Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System
FDA premarket approval P150003/S044 · decided 2018-12-14
Approval details
- PMA number
- P150003
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Synergy Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Boston Scientific Corporation
- Date received
- 2018-11-14
- Decision date
- 2018-12-14
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Reduction in the number of samples used for batch release and annual stability testing for the 4.50 and 5.00 mm stents.
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