Incraft AAA Stent Graft System
FDA premarket approval P150002/S002 · decided 2019-05-30
Approval details
- PMA number
- P150002
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Incraft AAA Stent Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cordis US Corporation
- Date received
- 2019-05-01
- Decision date
- 2019-05-30
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Movement of INCRAFT manufacturing to another building at the same facility and addition of a semi-automated process step during the inner member assembly.
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