SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail®), SYNERGY SHIELD Everolimus-Eluting Plat
FDA premarket approval P150003/S093 · decided 2023-06-12
Approval details
- PMA number
- P150003
- Supplement
- S093
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail®), SYNERGY SHIELD Everolimus-Eluting Plat
- Generic name
- Coronary drug-eluting stent
- Applicant
- Boston Scientific Corporation
- Date received
- 2023-03-14
- Decision date
- 2023-06-12
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for changes to the labeling, device packaging, and addition of the 48 mm device delivery system to allow for alignment of the product matrix to include the 48-mm stent size.
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