PMA P150002S003
- Device
- Incraft (R) AAA Stent Graft System
- Applicant
- Cordis US Corporation
- PMA number
- P150002
- Supplement
- S003
- Product code
- MIH
- Decision date
- 2019-06-21
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Movement of the manufacturing facility for a critical supplier.
Current openFDA PMA Record#
- Device
- Incraft (R) AAA Stent Graft System
- Applicant
- Cordis US Corporation
- PMA number
- P150002
- Supplement
- S003
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2019-06-21
- Decision code
- OK30
- Date received
- 2019-05-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Movement of the manufacturing facility for a critical supplier.