INCRAFT AAA Stent Graft System

FDA Premarket Approval P150002 S007

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a change to the hypotube supplier for the delivery system of the incraft aaa stent graft system.

DeviceINCRAFT AAA Stent Graft System
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantCordis Corporation
Date Received2019-08-12
Decision Date2020-03-17
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Cordis Corporation 6500 Paseo Padre Pkwy fremont, CA 94555

Supplemental Filings

Supplement NumberDateSupplement Type
P150002Original Filing
S007 2019-08-12 135 Review Track For 30-day Notice
S006 2019-07-22 30-day Notice
S005 2019-06-10 30-day Notice
S004 2019-05-24 30-day Notice
S003 2019-05-24 30-day Notice
S002 2019-05-01 30-day Notice
S001 2019-01-25 Normal 180 Day Track No User Fee

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