TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT SYSTEM & TALENT CONVERTER STENT GRAFT WITH THE XCELERANT SYSTEM
FDA premarket approval P070027/S033 · decided 2011-10-19
Approval details
- PMA number
- P070027
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT SYSTEM & TALENT CONVERTER STENT GRAFT WITH THE XCELERANT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2011-09-30
- Decision date
- 2011-10-19
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- MODIFICATION OF A WIPING PROCDURE.
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