MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
FDA premarket approval P990020/S019 · decided 2005-06-24
Approval details
- PMA number
- P990020
- Supplement
- S019
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2005-06-06
- Decision date
- 2005-06-24
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL TO ADD AN ADDITIONAL TENSILE TEST OF THE DELIVERY SYSTEM DURING THE DEVICE MANUFACTURING PROCESS.
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