LifeStent 5F Vascular Stent Systems
FDA premarket approval P070014/S061 · decided 2020-09-25
Approval details
- PMA number
- P070014
- Supplement
- S061
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LifeStent 5F Vascular Stent Systems
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2020-08-31
- Decision date
- 2020-09-25
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Alternate supplier of delivery system handle lock marking and thermoplastic staking processes.
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