Bard E-LUMINEXX and LIFESTAR Vascular Stents
FDA premarket approval P080007/S021 · decided 2018-01-16
Approval details
- PMA number
- P080007
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Bard E-LUMINEXX and LIFESTAR Vascular Stents
- Generic name
- STENT, ILIAC
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2017-12-15
- Decision date
- 2018-01-16
- Days to decision
- 32 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- Addition of alternate laser cutting equipment.
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