LIFESTENT SOLO VASCULAR STENT SYSTEM
FDA premarket approval P070014/S032 · decided 2012-05-25
Approval details
- PMA number
- P070014
- Supplement
- S032
- Supplement type
- Real-Time Process
- Trade name
- LIFESTENT SOLO VASCULAR STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2012-04-06
- Decision date
- 2012-05-25
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR MINOR CHANGES TO THE DIVING SHEATH WITH PULL WIRE COMPONENT OF THE DELIVERY SYSTEM.
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