ANEURX AAADVANTAGE STONE GRAFT WITH XCELERANT DELIVERY SYSTEM
FDA premarket approval P990020/S027 · decided 2007-10-26
Approval details
- PMA number
- P990020
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANEURX AAADVANTAGE STONE GRAFT WITH XCELERANT DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2007-09-27
- Decision date
- 2007-10-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- USE (BY THE CURRENT SUPPLIER OF BIFURCATED GRAFT COMPONENTS) OF AN ALTERNATE SUPPLIER OF POLYESTER YARN FOR THE MANUFACTURE OF ALL ANEURX AAADVANTAGE BIFURCATED AND ILIAC LIMB SUBCOMPONENT CONFIGURATIONS.
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