LIFESTENT VASCULAR STENT SYSTEMS
FDA premarket approval P070014/S018 · decided 2010-10-14
Approval details
- PMA number
- P070014
- Supplement
- S018
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- LIFESTENT VASCULAR STENT SYSTEMS
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2010-09-09
- Decision date
- 2010-10-14
- Days to decision
- 35 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 3 YEARS.
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