HANCOCK II PORCINE BIOPROSTHESIS

Replacement Heart-valve

FDA Premarket Approval P980043

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the medtronic hancock(r) ii bioprosthetic heart valve, models t505 (odd sizes 21 through 29 mm) and t510 (odd sizes 25 through 33 mm). This device is indicated for the replacement of pathologic or prosthetic aortic and mitral valves.

DeviceHANCOCK II PORCINE BIOPROSTHESIS
Classification NameReplacement Heart-valve
Generic NameReplacement Heart-valve
ApplicantMedtronic, Inc.
Date Received1998-10-29
Decision Date1999-09-28
Notice Date1999-10-15
PMAP980043
SupplementS
Product CodeDYE
Docket Number99M-4279
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic, Inc. 1851 East Deere Ave. santa Ana, CA 92705
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P980043Original Filing
S075 2020-11-19 30-day Notice
S074
S073 2020-04-08 30-day Notice
S072 2019-09-26 Real-time Process
S071 2019-06-20 30-day Notice
S070 2019-01-29 30-day Notice
S069
S068 2018-09-24 30-day Notice
S067 2018-06-21 30-day Notice
S066 2018-04-12 30-day Notice
S065 2017-12-20 30-day Notice
S064
S063 2017-09-11 30-day Notice
S062 2017-08-14 135 Review Track For 30-day Notice
S061 2017-07-10 30-day Notice
S060
S059 2017-03-24 135 Review Track For 30-day Notice
S058 2017-02-22 30-day Notice
S057 2017-02-08 30-day Notice
S056 2016-11-10 Real-time Process
S055 2016-10-25 30-day Notice
S054 2016-05-06 30-day Notice
S053 2016-05-02 30-day Notice
S052 2015-10-13 30-day Notice
S051 2014-11-07 30-day Notice
S050 2014-10-14 30-day Notice
S049 2014-08-05 30-day Notice
S048 2014-07-21 Normal 180 Day Track
S047 2014-06-23 30-day Notice
S046 2014-06-13 30-day Notice
S045 2014-04-23 30-day Notice
S044 2013-09-17 30-day Notice
S043 2013-07-01 30-day Notice
S042 2013-04-02 135 Review Track For 30-day Notice
S041 2013-04-01 135 Review Track For 30-day Notice
S040 2013-04-01 30-day Notice
S039 2013-02-13 30-day Notice
S038 2012-12-13 30-day Notice
S037 2012-11-29 30-day Notice
S036 2012-11-19 30-day Notice
S035 2012-03-14 30-day Notice
S034 2012-03-23 Normal 180 Day Track
S033 2011-08-17 30-day Notice
S032 2011-07-28 30-day Notice
S031
S030 2011-02-15 Real-time Process
S029 2010-10-21 30-day Notice
S028 2010-10-20 30-day Notice
S027 2010-06-18 30-day Notice
S026 2010-04-30 30-day Notice
S025 2010-03-11 30-day Notice
S024 2010-01-06 30-day Notice
S023 2010-01-06 135 Review Track For 30-day Notice
S022 2009-10-05 30-day Notice
S021 2009-07-31 Real-time Process
S020 2009-07-09 30-day Notice
S019
S018 2009-01-21 Real-time Process
S017 2008-05-20 Real-time Process
S016 2008-02-07 135 Review Track For 30-day Notice
S015 2007-11-13 Special (immediate Track)
S014 2007-10-15 30-day Notice
S013 2007-09-19 30-day Notice
S012 2007-06-19 Real-time Process
S011
S010 2006-08-03 30-day Notice
S009 2006-02-06 Real-time Process
S008 2005-12-30 30-day Notice
S007 2005-12-27 135 Review Track For 30-day Notice
S006
S005 2004-09-23 Real-time Process
S004 2003-12-22 Special (immediate Track)
S003
S002 2002-05-01 Normal 180 Day Track
S001 2002-04-08 Special (immediate Track)

NIH GUDID Devices

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