BARD E-LUMINEXX VASCULAR STENT
FDA premarket approval P080007/S019 · decided 2014-01-22
Approval details
- PMA number
- P080007
- Supplement
- S019
- Supplement type
- Special (Immediate Track)
- 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
- 2013-12-24
- Decision date
- 2014-01-22
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR AN ADDITIONAL LABELING VERIFICATION INSPECTION METHOD FOR THE DEVICE PACKAGING.
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