Innova Vascular Self-Expanding Stent System
FDA premarket approval P140028/S053 · decided 2020-04-16
Approval details
- PMA number
- P140028
- Supplement
- S053
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Innova Vascular Self-Expanding Stent System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Boston Scientific Corporation
- Date received
- 2020-01-24
- Decision date
- 2020-04-16
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for a change to the material of construction for a delivery system component.
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