LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS
FDA premarket approval P070014/S007 · decided 2010-06-11
Approval details
- PMA number
- P070014
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2009-12-14
- Decision date
- 2010-06-11
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR A CHANGE IN LABELING THAT UPDATES THE INSTRUCTIONS FOR USE AND THE PATIENT INFORMATION BROCHURE TO INCLUDE THE MOST RECENT CLINICAL DATA UP TO 2 YEARS.
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