SYNERGY SHIELD Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System, YNERGY MEGATRON Monorail Everolimu
FDA premarket approval P150003/S102 · decided 2024-10-01
Approval details
- PMA number
- P150003
- Supplement
- S102
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYNERGY SHIELD Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System, YNERGY MEGATRON Monorail Everolimu
- Generic name
- Coronary drug-eluting stent
- Applicant
- Boston Scientific Corporation
- Date received
- 2024-07-01
- Decision date
- 2024-10-01
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- the removal of the polytetrafluoroethylene (PTFE) coating on the delivery system hypotube and the addition of black ink proximal markers
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