ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM
FDA premarket approval P990020/S035 · decided 2009-09-01
Approval details
- PMA number
- P990020
- Supplement
- S035
- Supplement type
- 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
- 2009-08-04
- Decision date
- 2009-09-01
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- ALTERNATIVE TESTING FACILITY AND CHANGES TO THE SAMPLING PLAN FOR THE FINISHED DEVICE LAL TESTING.
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