INCRAFT(R) AAA Stent Graft System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Premarket Approval P150002 S004

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

The transfer of final release activities from the cordis miami lakes site to the cordis de mexico site

DeviceINCRAFT(R) AAA Stent Graft System
Classification NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantCordis Corporation
Date Received2019-05-24
Decision Date2019-06-21
PMAP150002
SupplementS004
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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