BARD E-LUMINEXX VASCULAR STENT
FDA premarket approval P080007/S010 · decided 2011-12-07
Approval details
- PMA number
- P080007
- Supplement
- S010
- 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
- 2011-11-14
- Decision date
- 2011-12-07
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- THE SURFACE TREATMENT OF THE STENT TO BE PERFORMED AT AN ALTERNATE SUPPLIER AND THE ADDITION OF SEVERAL OPTIMIZATIONS TO THE PROCESS FLOW.
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