LifeStent Vascular Stent System
FDA premarket approval P070014/S065 · decided 2023-07-27
Approval details
- PMA number
- P070014
- Supplement
- S065
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- LifeStent Vascular Stent System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2023-02-21
- Decision date
- 2023-07-27
- Days to decision
- 156 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval to update the labeling to include clinical results from the LifeStent Vascular Stent Systems post-approval study (Popliteal Indication)
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