BARD LIFESTENT VASCULAR STENT
FDA premarket approval P070014/S046 · decided 2014-06-17
Approval details
- PMA number
- P070014
- Supplement
- S046
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BARD LIFESTENT VASCULAR STENT
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2014-05-20
- Decision date
- 2014-06-17
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- OPTIONAL PROCESS FOR TRANSFERRING A STENT TO A NEW DELIVERY SYSTEM CATHETER.
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