PMA P070007S011
- Device
- TALENT THORACIC STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P070007
- Supplement
- S011
- Product code
- MIH
- Decision date
- 2009-09-01
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- ALTERNATIVE TESTING FACILITY AND CHANGES TO THE SAMPLING PLAN FOR THE FINISHED DEVICE LAL TESTING.
Current openFDA PMA Record
- Device
- TALENT THORACIC STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P070007
- Supplement
- S011
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2009-09-01
- Decision code
- OK30
- Date received
- 2009-08-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATIVE TESTING FACILITY AND CHANGES TO THE SAMPLING PLAN FOR THE FINISHED DEVICE LAL TESTING.