ANEURX STENT GRAFT SYSTEM
FDA premarket approval P990020/S003 · decided 2000-02-08
Approval details
- PMA number
- P990020
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANEURX STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2000-01-21
- Decision date
- 2000-02-08
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- The 30-day notice reqeusted changes to eliminate a final cleaning step and to add a supplier of nitinol tubing and as-cut stents.
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