ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
FDA premarket approval P990020/S017 · decided 2004-10-28
Approval details
- PMA number
- P990020
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2004-08-04
- Decision date
- 2004-10-28
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR MODIFICATIONS MADE TO THE ANEURX DELIVERY SYSTEM, A CHANGE IN STERILIZATION METHOD, AND CHANGES TO THE INSTRUCTIONS FOR USE.
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