Trifecta™ Valve with Glide Technology (Trifecta GT)

FDA Premarket Approval P100029 S045

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

Discontinuation of passive monitoring procedures in iso class 7 and 8 cleanrooms

DeviceTrifecta™ Valve with Glide Technology (Trifecta GT)
Generic NameHeart-valve, Non-allograft Tissue
ApplicantAbbott Medical
Date Received2021-11-08
Decision Date2021-12-16
PMAP100029
SupplementS045
Product CodeLWR 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Medical 177 County Road B. East st. Paul, MN 55117

Supplemental Filings

Supplement NumberDateSupplement Type
P100029Original Filing
S045 2021-11-08 30-day Notice
S044
S043 2020-09-15 30-day Notice
S042 2019-11-13 30-day Notice
S041
S040 2019-05-09 30-day Notice
S039 2019-02-27 30-day Notice
S038 2019-02-13 30-day Notice
S037 2018-10-23 30-day Notice
S036 2018-09-12 30-day Notice
S035 2018-08-13 Special (immediate Track)
S034 2018-05-14 30-day Notice
S033 2018-03-27 30-day Notice
S032 2018-03-22 30-day Notice
S031 2018-02-15 30-day Notice
S030 2018-02-01 30-day Notice
S029 2018-01-11 30-day Notice
S028 2017-11-28 30-day Notice
S027 2017-10-27 30-day Notice
S026
S025 2017-03-07 30-day Notice
S024 2016-12-22 30-day Notice
S023 2016-12-09 30-day Notice
S022 2016-07-01 30-day Notice
S021 2015-10-02 Normal 180 Day Track
S020 2015-08-28 30-day Notice
S019 2015-01-21 30-day Notice
S018 2014-11-13 30-day Notice
S017 2014-09-05 30-day Notice
S016 2013-06-10 135 Review Track For 30-day Notice
S015 2013-05-28 135 Review Track For 30-day Notice
S014 2012-07-19 Special (immediate Track)
S013 2012-04-05 Real-time Process
S012 2012-03-27 30-day Notice
S011 2012-03-22 Special (immediate Track)
S010 2012-01-23 30-day Notice
S009 2011-09-27 30-day Notice
S008 2011-08-17 Real-time Process
S007 2011-08-08 30-day Notice
S006 2011-06-09 30-day Notice
S005 2011-06-06 30-day Notice
S004 2011-06-06 135 Review Track For 30-day Notice
S003 2011-05-20 Normal 180 Day Track No User Fee
S002 2011-04-27 135 Review Track For 30-day Notice
S001 2011-04-22 30-day Notice

NIH GUDID Devices

Device IDPMASupp
05414734052016 P100029 000
05414734052023 P100029 000
05414734052030 P100029 000
05414734052047 P100029 000
05414734052054 P100029 000
05414734052061 P100029 000
05415067018205 P100029 021
05415067018212 P100029 021
05415067018229 P100029 021
05415067018236 P100029 021
05415067018243 P100029 021
05415067018250 P100029 021

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