LIFESTENT VASCULAR STENT SYSTEMS
FDA premarket approval P070014/S048 · decided 2016-03-11
Approval details
- PMA number
- P070014
- Supplement
- S048
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFESTENT VASCULAR STENT SYSTEMS
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2015-11-04
- Decision date
- 2016-03-11
- Days to decision
- 128 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval of a 250 mm stent length.
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