BARD LIFESTENT SOLO VASCULAR STENT SYSTEMS
FDA premarket approval P070014/S027 · decided 2011-11-17
Approval details
- PMA number
- P070014
- Supplement
- S027
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BARD LIFESTENT SOLO VASCULAR STENT SYSTEMS
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2011-10-03
- Decision date
- 2011-11-17
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR A SMALLER PACKAGING CONFIGURATION AND MINOR LABELING CHANGES TO ACCOMMODATE THE CHANGES TO THE PACKAGING.
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