INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM
FDA premarket approval P140028/S010 · decided 2016-05-11
Approval details
- PMA number
- P140028
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Boston Scientific Corporation
- Date received
- 2016-03-14
- Decision date
- 2016-05-11
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval of the Boston Scientific Maple Grove site as a stent component manufacturing site for the Innova stent.
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