TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT HYDRO DELIVERY SYSTEM
FDA premarket approval P070027/S012 · decided 2009-10-23
Approval details
- PMA number
- P070027
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TALENT ABDOMINAL STENT GRAFT WITH THE XCELERANT HYDRO DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2009-09-17
- Decision date
- 2009-10-23
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC CARDIAC SURGERY, MEDTRONIC PERFUSION SYSTEMS, MINNEAPOLIS, MINNESOTA. THE PROPOSED SITE WILL BE PERFORMING REWORK OF PACKAGING AND LABELING.
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