PMA P150002S010

Device: INCRAFT AAA Stent Graft System
Applicant: Cordis US Corporation
PMA number: P150002
Supplement: S010
Product code: MIH
Decision date: 2021-05-26
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Implementation of a change in raw material and its supplier for the body of the Stopcock-Luer Cap Assembly of INCRAFT AAA Stent Graft delivery system.

Current openFDA PMA Record#

Device: INCRAFT AAA Stent Graft System
Applicant: Cordis US Corporation
PMA number: P150002
Supplement: S010
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2021-05-26
Decision code: OK30
Date received: 2021-04-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of a change in raw material and its supplier for the body of the Stopcock-Luer Cap Assembly of INCRAFT AAA Stent Graft delivery system.