PMA P070007S037
- Device
- TALENT THORACIC STENT GRAFT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P070007
- Supplement
- S037
- Product code
- MIH
- Decision date
- 2013-05-02
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- ADD MANUFACTURING STEPS RELATED TO THE STENT RING AND MARKERS TO AN EXISTING INTERNAL MANUFACTURING FACILITY.
Current openFDA PMA Record
- Device
- TALENT THORACIC STENT GRAFT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P070007
- Supplement
- S037
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2013-05-02
- Decision code
- OK30
- Date received
- 2013-04-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD MANUFACTURING STEPS RELATED TO THE STENT RING AND MARKERS TO AN EXISTING INTERNAL MANUFACTURING FACILITY.