ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM
FDA premarket approval P990020/S036 · decided 2010-01-21
Approval details
- PMA number
- P990020
- Supplement
- S036
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2009-09-11
- Decision date
- 2010-01-21
- Days to decision
- 132 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR A CHANGE IN THE MANUFACTURING LOCATION OF THE DEVICE WITHIN THE MEDTRONIC IRELAND CAMPUS.
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