PMA P990020S002
- Device
- ANEURX STENT GRAFT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P990020
- Supplement
- S002
- Product code
- MIH
- Decision date
- 2000-02-08
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- The 30-day notice requested changes to eliminate a final cleaning step and to add a supplier of nitinol tubing and as-cut stents.
Current openFDA PMA Record
- Device
- ANEURX STENT GRAFT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P990020
- Supplement
- S002
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2000-02-08
- Decision code
- OK30
- Date received
- 2000-01-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-day notice requested changes to eliminate a final cleaning step and to add a supplier of nitinol tubing and as-cut stents.