ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM
FDA premarket approval P990020/S015 · decided 2004-01-30
Approval details
- PMA number
- P990020
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2003-08-05
- Decision date
- 2004-01-30
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR USE OF A HIGH-DENSITY GRAFT MATERIAL (HDM) IN THE MANUFACTURE OF THE ANEURX STENT GRAFT.
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