ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
FDA premarket approval P990020/S018 · decided 2005-06-17
Approval details
- PMA number
- P990020
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2005-05-20
- Decision date
- 2005-06-17
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- CHANGE IN THE MANUFACTURING PROCESS IMPLEMENTING ADDITIONAL INSPECTION AND PROCESS CLARIFICATIONS TO ENSURE PROPER FUNCTION OF THE XCELERANT DELIVERY SYSTEM USED TO DELIVER THE ANEURX STENT GRAFT.
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