MEDTRONIC VASCULAR TALENT ABDOMINAL STANT GRAFT SYSTEM
FDA premarket approval P070027/S008 · decided 2009-03-16
Approval details
- PMA number
- P070027
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC VASCULAR TALENT ABDOMINAL STANT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2009-02-18
- Decision date
- 2009-03-16
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- TEMPORARY REWORK OF THE TALENT ABDOMINAL AND TALENT THORACIC STENT GRAFT SYSTEMS FOR THE COILTRAC DELIVERY SYSTEM TO THE XCELERANT DELIVERY SYSTEM.
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