BRAD E-LUMINEXX VASCULAR STENT SYSTEM
FDA premarket approval P080007/S017 · decided 2013-07-02
Approval details
- PMA number
- P080007
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRAD E-LUMINEXX VASCULAR STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2013-06-04
- Decision date
- 2013-07-02
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- ADD AN ALTERNATE SUPPLIER FOR THE CATHETER SHAFT IN YOUR DELIVERY SYSTEM.
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