BARD E-LUMINEXX VASCULAR STENT
FDA premarket approval P080007/S013 · decided 2012-04-27
Approval details
- PMA number
- P080007
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BARD E-LUMINEXX VASCULAR STENT
- Generic name
- STENT, ILIAC
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2012-04-02
- Decision date
- 2012-04-27
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- UPDATES TO EXISTING RAW MATERIAL INSPECTION EQUIPMENT AND THE ADDITION OF NEW RAW MATERIAL INSPECTION EQUIPMENT.
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