E-Luminexx® Vascular Stent
FDA premarket approval P080007/S026 · decided 2021-11-23
Approval details
- PMA number
- P080007
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- E-Luminexx® Vascular Stent
- Generic name
- STENT, ILIAC
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2021-08-26
- Decision date
- 2021-11-23
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Approval for modifying the materials of the packaging sterile barrier.
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