PMA P150002
- Device
- INCRAFT® AAA Stent Graft System
- Applicant
- Cordis US Corporation
- PMA number
- P150002
- Supplement
- S010
- Product code
- MIH
- Decision date
- 2025-05-15
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- removal of redundant Product Final Inspector steps
Current openFDA PMA Record#
- Device
- INCRAFT® AAA Stent Graft System
- Applicant
- Cordis US Corporation
- PMA number
- P150002
- Supplement
- S012
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2025-05-15
- Decision code
- OK30
- Date received
- 2025-05-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- removal of redundant Product Final Inspector steps