E-LUMINEXX VASCULAR STENT
FDA premarket approval P080007/S015 · decided 2013-04-12
Approval details
- PMA number
- P080007
- Supplement
- S015
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- E-LUMINEXX VASCULAR STENT
- Generic name
- STENT, ILIAC
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2012-11-09
- Decision date
- 2013-04-12
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS BELGIUM PETIT RECHAIN, S.A., IN VERVIERS, BELGIUM.
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