ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM
FDA premarket approval P990020/S014 · decided 2003-08-08
Approval details
- PMA number
- P990020
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2003-07-14
- Decision date
- 2003-08-08
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- CHANGE IN THE MANUFACTURING PROCESS OF THE ANEURX STENT GRAFT WITH XPEDIENT DELIVERY SYSTEM WHICH INVOLVES A CHANGE IN THE METHOD OF THE JOINING PROCESS FROM ADHESIVE TO LASER-WELD FOR BOTH THE 16 FR AND 12 FR DELIVERY SYSTEMS.
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