PMA P150002S008
- Device
- INCRAFT(R) AAA STENT GRAFT SYSTEM
- Applicant
- Cordis US Corporation
- PMA number
- P150002
- Supplement
- S008
- Product code
- MIH
- Decision date
- 2020-09-23
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval for updating the labeling to include 5-year INSPIRATION study data and minor editorial changes.
Current openFDA PMA Record#
- Device
- INCRAFT(R) AAA STENT GRAFT SYSTEM
- Applicant
- Cordis US Corporation
- PMA number
- P150002
- Supplement
- S008
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2020-09-23
- Decision code
- APPR
- Date received
- 2020-03-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updating the labeling to include 5-year INSPIRATION study data and minor editorial changes.