HANCOCK MODIFIED ORIFICE (MO) VALUED CONDUIT

Heart-valve, Non-allograft Tissue

FDA Premarket Approval P790007 S040

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 a design change to the rubber gasket for the jar used to package the device.

DeviceHANCOCK MODIFIED ORIFICE (MO) VALUED CONDUIT
Classification NameHeart-valve, Non-allograft Tissue
Generic NameHeart-valve, Non-allograft Tissue
ApplicantMEDTRONIC HEART VALVES
Date Received2013-10-25
Decision Date2013-11-14
PMAP790007
SupplementS040
Product CodeLWR
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC HEART VALVES 1851 East Deere Ave. santa Ana, CA 92705

Supplemental Filings

Supplement NumberDateSupplement Type
P790007Original Filing
S064 2020-11-19 30-day Notice
S063
S062 2019-09-26 Real-time Process
S061 2019-06-20 30-day Notice
S060 2019-01-29 30-day Notice
S059
S058 2018-10-01 30-day Notice
S057 2018-06-21 30-day Notice
S056 2018-04-12 30-day Notice
S055 2017-12-20 30-day Notice
S054
S053 2017-09-11 30-day Notice
S052 2017-08-14 135 Review Track For 30-day Notice
S051 2017-07-10 30-day Notice
S050 2017-02-08 30-day Notice
S049 2016-10-25 30-day Notice
S048 2016-05-06 30-day Notice
S047 2016-01-29 Real-time Process
S046 2015-10-13 30-day Notice
S045 2014-11-07 30-day Notice
S044 2014-10-14 30-day Notice
S043 2014-08-05 30-day Notice
S042 2014-06-23 30-day Notice
S041 2014-04-23 30-day Notice
S040 2013-10-25 Real-time Process
S039 2013-07-01 30-day Notice
S038 2013-04-02 135 Review Track For 30-day Notice
S037 2013-04-01 135 Review Track For 30-day Notice
S036 2013-04-01 30-day Notice
S035 2013-02-13 30-day Notice
S034 2012-12-13 30-day Notice
S033 2012-11-19 30-day Notice
S032 2012-03-23 Normal 180 Day Track
S031 2011-08-17 30-day Notice
S030 2011-07-28 30-day Notice
S029
S028 2010-10-21 30-day Notice
S027 2010-10-20 30-day Notice
S026 2010-06-18 30-day Notice
S025 2010-04-30 30-day Notice
S024 2010-01-06 135 Review Track For 30-day Notice
S023 2009-10-05 30-day Notice
S022 2009-07-09 30-day Notice
S021 2007-10-15 30-day Notice
S020 2007-09-19 30-day Notice
S019
S018 2007-04-13 30-day Notice
S017 2005-12-27 135 Review Track For 30-day Notice
S016 1999-08-31 Normal 180 Day Track
S015 1998-05-12 Normal 180 Day Track
S014 1998-04-06 Normal 180 Day Track
S013 1996-05-13 Normal 180 Day Track
S012 1993-04-12 Normal 180 Day Track
S011 1992-12-18 Normal 180 Day Track
S010 1992-07-20 Normal 180 Day Track
S009 1989-07-26 Normal 180 Day Track
S008
S007 1985-02-08
S006
S005 1981-05-04
S004 1980-10-06
S003 1979-12-27
S002 1979-12-27
S001 1979-12-27

NIH GUDID Devices

Device IDPMASupp
00681490908726 P790007 011
00681490908740 P790007 011
00681490908764 P790007 011
00681490908788 P790007 011
00681490908795 P790007 011
00681490908818 P790007 011
00681490908832 P790007 011
00643169646551 P790007 047
00643169646568 P790007 047
00643169646575 P790007 047
00643169646582 P790007 047
00643169646599 P790007 047
00643169646605 P790007 047
00643169646612 P790007 047

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