ANEURX STENT GRAFT SYSTEM
FDA premarket approval P990020/S011 · decided 2002-10-24
Approval details
- PMA number
- P990020
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- ANEURX STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2002-09-24
- Decision date
- 2002-10-24
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT MEDTRONIC AVE, INC., SANTA ROSA, CALIFORNIA.
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