ANEURX STENT GRAFT SYSTEM
FDA premarket approval P990020/S032 · decided 2008-09-11
Approval details
- PMA number
- P990020
- Supplement
- S032
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANEURX STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2008-03-31
- Decision date
- 2008-09-11
- Days to decision
- 164 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ISOTRON PLC, DAVENTRY, UNITED KINGDOM, FOR E-BEAM STERILIZATION.
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