INCRAFT AAA Stent Graft System

FDA Premarket Approval P150002 S010

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

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

DeviceINCRAFT AAA Stent Graft System
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantCordis Corporation
Date Received2021-04-26
Decision Date2021-05-26
PMAP150002
SupplementS010
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement Type30-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
S010 2021-04-26 30-day Notice
S009
S008 2020-03-31 Normal 180 Day Track No User Fee
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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