PMA P070007S027
- Device
- Talent Thoracic Stent Graft System
- Applicant
- Medtronic Vascular
- PMA number
- P070007
- Supplement
- S027
- Decision date
- 2011-02-07
Current openFDA PMA Record
- Device
- TALENT THORACIC STENT GRAFT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P070007
- Supplement
- S027
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2011-02-07
- Decision code
- OK30
- Date received
- 2011-01-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO SAMPLE NUMBERS FOR ENDOTOXIN TESTING AND A LOT DEFINITION CHANGE.