LIFESTENT SOLO VASCULAR STENT SYSTEM
FDA premarket approval P070014/S026 · decided 2011-10-26
Approval details
- PMA number
- P070014
- Supplement
- S026
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LIFESTENT SOLO VASCULAR STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2011-09-26
- Decision date
- 2011-10-26
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR MODIFICATIONS TO THE PRODUCT LABELING, PREDOMINANTLY WITH RESPECT TO IMPROVING THE SAFE USE OF THE DEVICE BY MODIFYING THE STENT DEPLOYMENT PROCEDURE LANGUAGE IN THE INSTRUCTIONS FOR USE, AS WELL AS ADDING NEW SYMBOLS TO THE LABELING.
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