LIFESTENT AND LIFESYENT XL VASCULAR STENT SYSTEMS
FDA premarket approval P070014/S006 · decided 2009-12-08
Approval details
- PMA number
- P070014
- Supplement
- S006
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LIFESTENT AND LIFESYENT XL VASCULAR STENT SYSTEMS
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2009-11-20
- Decision date
- 2009-12-08
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR THE PROPOSED CHANGE IN PRODUCT LABELING THAT AFFECTS THE STENT DEPLOYMENT PROCEDURES WITHIN THE INSTRUCTIONS FOR USE.
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