INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM
FDA premarket approval P140028/S019 · decided 2016-11-01
Approval details
- PMA number
- P140028
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Boston Scientific Corporation
- Date received
- 2016-10-03
- Decision date
- 2016-11-01
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Alternate supplier for a manufacturing aid.
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