TALENT ABDOMINAL STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
FDA premarket approval P070027/S007 · decided 2009-03-09
Approval details
- PMA number
- P070027
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TALENT ABDOMINAL STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2009-02-13
- Decision date
- 2009-03-09
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- CHANGE FROM A MANUAL TO AN AUTOMATED PROCESS FOR CUTTING AND SEALING THE GRAFT MATERIAL.
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