ANEURX STENT GRAFT SYSTEM
FDA premarket approval P990020/S010 · decided 2002-12-23
Approval details
- PMA number
- P990020
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ANEURX STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2002-09-13
- Decision date
- 2002-12-23
- Days to decision
- 101 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE FORMAT TO BE USED FOR A CLINICAL UPDATE THAT WILL BE PROVIDED TO PHYSICIAN USERS AT LEAST ANNUALLY. THE INFORMATION CONTAINED IN THIS UPDATE WILL BE PROVIDED TO THE FDA VIA THE PMA ANNUAL REPORT.
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