ANEURX STENT GRAFT SYSTEM
FDA premarket approval P990020/S006 · decided 2002-02-07
Approval details
- PMA number
- P990020
- Supplement
- S006
- 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
- 2000-11-13
- Decision date
- 2002-02-07
- Days to decision
- 451 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR REVISIONS TO THE LABELING FOR THE DEVICE.
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