BARD LIFESTENT VASCULAR STENT SYSTEM
FDA premarket approval P070014/S003 · decided 2009-09-01
Approval details
- PMA number
- P070014
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BARD LIFESTENT VASCULAR STENT SYSTEM
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2009-08-04
- Decision date
- 2009-09-01
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- ADDITION OF AN IN HOUSE SUPPLIER FOR SHEATH COMPONENTS AND EXTENSION OF THE SHELF LIFE FOR A SHEATH COMPONENT.
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