Hancock II Bioprothesis

FDA Premarket Approval P980043 S073

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

A new inspection method for detecting pin sized gaps between valve leaflets

DeviceHancock II Bioprothesis
Generic NameReplacement Heart-valve
ApplicantMedtronic, Inc.
Date Received2020-04-08
Decision Date2020-05-06
PMAP980043
SupplementS073
Product CodeDYE 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic, Inc. 1851 East Deere Ave. santa Ana, CA 92705

Supplemental Filings

Supplement NumberDateSupplement Type
P980043Original Filing
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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