PMA P070007S026
- Device
- Talent Thoracic Stent Graft System
- Applicant
- Medtronic Vascular
- PMA number
- P070007
- Supplement
- S026
- Decision date
- 2011-04-12
Current openFDA PMA Record
- Device
- TALENT THORACIC STENT GRAFT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P070007
- Supplement
- S026
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2011-04-12
- Decision code
- APPR
- Date received
- 2010-12-10
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO EXTEND THE SCOPE OF THE RECEIVING AND MANUFACTURING ACTIVITIES CONDUCTED AT A THIRD PARTY STORAGE LOCATION.