Mitroflow Aortic Pericardial Heart Valve

Heart-valve, Non-allograft Tissue

FDA Premarket Approval P060038 S033

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

Terminate nemo pas

DeviceMitroflow Aortic Pericardial Heart Valve
Classification NameHeart-valve, Non-allograft Tissue
Generic NameHeart-valve, Non-allograft Tissue
ApplicantLivaNova Canada Corp.
Date Received2019-04-08
Decision Date2019-11-21
PMAP060038
SupplementS033
Product CodeLWR
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
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

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