PMA P070007S012
- Device
- Talent Thoracic Stent Graft With The Xcelerant Del
- Applicant
- Medtronic Vascular
- PMA number
- P070007
- Supplement
- S012
- Decision date
- 2009-10-23
Current openFDA PMA Record
- Device
- TALENT THORACIC STENT GRAFT WITH THE XCELERANT DELIVERY SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P070007
- Supplement
- S012
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2009-10-23
- Decision code
- APPR
- Date received
- 2009-09-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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.