PMA P150002S007
- Device
- INCRAFT AAA Stent Graft System
- Applicant
- Cordis US Corporation
- PMA number
- P150002
- Supplement
- S007
- Product code
- MIH
- Decision date
- 2020-03-17
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval for a change to the hypotube supplier for the delivery system of the INCRAFT AAA Stent Graft System.
Current openFDA PMA Record#
- Device
- INCRAFT AAA Stent Graft System
- Applicant
- Cordis US Corporation
- PMA number
- P150002
- Supplement
- S007
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2020-03-17
- Decision code
- APPR
- Date received
- 2019-08-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to the hypotube supplier for the delivery system of the INCRAFT AAA Stent Graft System.