BARD LIFESTENT VASCULAR STENT SYSTEM
FDA premarket approval P070014/S051 · decided 2016-08-31
Approval details
- PMA number
- P070014
- Supplement
- S051
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- BARD LIFESTENT VASCULAR STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2016-07-01
- Decision date
- 2016-08-31
- Days to decision
- 61 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval of the post-approval study protocol.
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