Bard LifeStent 5F Vascular Stent System
FDA premarket approval P070014/S055 · decided 2018-08-01
Approval details
- PMA number
- P070014
- Supplement
- S055
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Bard LifeStent 5F Vascular Stent System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2018-06-01
- Decision date
- 2018-08-01
- Days to decision
- 61 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval for a labeling change to add 0.014 guidewires for use with the LifeStent 5F Vascular Stent System.
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