MITROFLOW AORTIC PERICARDIAL HEART VALVE

Heart-valve, Non-allograft Tissue

FDA Premarket Approval P060038 S029

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 the addition of a new bovine tissue supplier.

DeviceMITROFLOW AORTIC PERICARDIAL HEART VALVE
Classification NameHeart-valve, Non-allograft Tissue
Generic NameHeart-valve, Non-allograft Tissue
ApplicantLivaNova Canada Corp.
Date Received2016-08-11
Decision Date2016-09-23
PMAP060038
SupplementS029
Product CodeLWR
Advisory CommitteeCardiovascular
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address LivaNova Canada Corp. 5005 North Fraser Way burnaby V5J 5

Supplemental Filings

Supplement NumberDateSupplement Type
P060038Original Filing
S033 2019-04-08 Normal 180 Day Track No User Fee
S032 2018-06-15 30-day Notice
S031 2017-12-26 135 Review Track For 30-day Notice
S030 2016-08-16 30-day Notice
S029 2016-08-11 135 Review Track For 30-day Notice
S028 2016-06-17 30-day Notice
S027 2016-03-31 30-day Notice
S026 2015-11-04 Real-time Process
S025 2015-09-28 Real-time Process
S024 2015-09-22 Real-time Process
S023 2015-03-27 30-day Notice
S022 2014-12-22 30-day Notice
S021 2014-09-22 Normal 180 Day Track No User Fee
S020 2014-05-16 Normal 180 Day Track No User Fee
S019 2014-02-24 30-day Notice
S018 2013-10-28 30-day Notice
S017 2013-07-01 Normal 180 Day Track
S016
S015 2012-10-04 30-day Notice
S014 2012-07-10 30-day Notice
S013
S012 2012-04-12 Normal 180 Day Track No User Fee
S011 2012-02-21 30-day Notice
S010 2011-07-22 135 Review Track For 30-day Notice
S009 2011-01-05 30-day Notice
S008 2010-12-23 30-day Notice
S007 2010-06-11 30-day Notice
S006 2009-07-22 30-day Notice
S005 2009-07-08 30-day Notice
S004 2009-05-27 135 Review Track For 30-day Notice
S003 2009-03-19 30-day Notice
S002 2008-12-29 Real-time Process
S001 2008-04-02 135 Review Track For 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00896208000559 P060038 002
00896208000139 P060038 002
00896208000122 P060038 002
00896208000115 P060038 002
00896208000108 P060038 002
00896208000092 P060038 002
08022057014955 P060038 012
08022057014948 P060038 012
08022057014931 P060038 012
08022057014924 P060038 012
00896208000160 P060038 017
00896208000153 P060038 017
00896208000191 P060038 017
00896208000184 P060038 017
00896208000177 P060038 017
00896208000504 P060038 026
00896208000528 P060038 026
00896208000535 P060038 026
00896208000542 P060038 026
00896208000511 P060038 026
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