Artegraft Collagen Vascular Graft

FDA Premarket Approval N16837 S026

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 an additional cleanroom and water system

DeviceArtegraft Collagen Vascular Graft
Generic NameTissue Graft Of 6mm And Greater
ApplicantARTEGRAFT, INC.
Date Received2020-04-07
Decision Date2020-05-06
PMAN16837
SupplementS026
Product CodeLXA 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ARTEGRAFT, INC. 206-208b North Center Drive north Brunswick, NJ 08902

Supplemental Filings

Supplement NumberDateSupplement Type
N16837Original Filing
S026 2020-04-07 30-day Notice
S025 2018-06-15 30-day Notice
S024 2017-12-29 30-day Notice
S023 2017-12-19 30-day Notice
S022 2017-08-16 30-day Notice
S021 2015-09-11 Real-time Process
S020 2015-04-01 Special (immediate Track)
S019 2015-03-06 Real-time Process
S018 2014-09-04 30-day Notice
S017 2014-07-30 30-day Notice
S016
S015 2014-07-07 Special (immediate Track)
S014 2014-06-11 Real-time Process
S013
S012 2014-02-27 30-day Notice
S011 2013-04-26 Normal 180 Day Track No User Fee
S010 2012-09-24 135 Review Track For 30-day Notice
S009 2011-12-28 135 Review Track For 30-day Notice
S008 2011-09-20 135 Review Track For 30-day Notice
S007 2009-06-22 30-day Notice
S006 2008-08-11 135 Review Track For 30-day Notice
S005 2006-11-03 Real-time Process
S004 2006-02-01 30-day Notice
S003 1999-07-29 Normal 180 Day Track
S002
S001 1979-06-29

NIH GUDID Devices

Device IDPMASupp
00316837000367 N16837 000
00316837000190 N16837 015
00316837000206 N16837 015
00316837000213 N16837 015
00316837000220 N16837 015
00316837000237 N16837 015
00316837000244 N16837 015
00316837000251 N16837 015
00316837000268 N16837 015
00316837000275 N16837 015
00316837000282 N16837 015
00316837000299 N16837 015
00316837000305 N16837 015
00316837000312 N16837 015
00316837000329 N16837 015
00316837000336 N16837 015
00316837000343 N16837 015
00316837000350 N16837 015

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