Bard E-Luminexx Vascular Stent
FDA premarket approval P080007/S022 · decided 2019-07-11
Approval details
- PMA number
- P080007
- Supplement
- S022
- 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
- 2019-06-18
- Decision date
- 2019-07-11
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Addition of an in-process weld inspection step.
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