INCRAFT AAA Stent Graft System
FDA premarket approval P150002/S007 · decided 2020-03-17
Approval details
- PMA number
- P150002
- Supplement
- S007
- Supplement type
- 135 Review Track For 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
- 2019-08-12
- Decision date
- 2020-03-17
- Days to decision
- 218 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval for a change to the hypotube supplier for the delivery system of the INCRAFT AAA Stent Graft System.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.