LIFESTENT VASCULAR STENT SYSTEM
FDA premarket approval P070014/S034 · decided 2012-09-21
Approval details
- PMA number
- P070014
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIFESTENT VASCULAR STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2012-08-22
- Decision date
- 2012-09-21
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- ADDITION OF AN ALTERNATE SUPPLIER FOR TANTALUM MARKERS.
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