BARD LIFESTENT VASCULAR STENT SYSTEMS
FDA premarket approval P070014/S023 · decided 2011-10-27
Approval details
- PMA number
- P070014
- Supplement
- S023
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BARD LIFESTENT VASCULAR STENT SYSTEMS
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2011-05-20
- Decision date
- 2011-10-27
- Days to decision
- 160 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ANGIOMED GMBH & CO. IN KARLSRUHE, GERMANY.
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