LifeStent 5F Vascular Stent System
FDA premarket approval P070014/S068 · decided 2026-05-15
Approval details
- PMA number
- P070014
- Supplement
- S068
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LifeStent 5F Vascular Stent System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2026-03-04
- Decision date
- 2026-05-15
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval for enhancing the flexibility of the inner catheter component
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