LifeStent Vascular Stent Systems
FDA premarket approval P070014/S060 · decided 2021-05-19
Approval details
- PMA number
- P070014
- Supplement
- S060
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LifeStent Vascular Stent Systems
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2020-05-21
- Decision date
- 2021-05-19
- Days to decision
- 363 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval an alternate supplier for the primary and secondary sheath components of the LifeStent Vascular Stent Systems.
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