HANCOCK II PORCINE BIOPROSTHESIS

Replacement Heart-valve

FDA Premarket Approval P980043 S016

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 to replace the inspection of sub-assemblies with process monitoring.

DeviceHANCOCK II PORCINE BIOPROSTHESIS
Classification NameReplacement Heart-valve
Generic NameReplacement Heart-valve
ApplicantMedtronic, Inc.
Date Received2008-02-07
Decision Date2008-07-01
PMAP980043
SupplementS016
Product CodeDYE
Advisory CommitteeCardiovascular
Supplement Type135 Review Track For 30-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
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

Device IDPMASupp
00613994687036 P980043 000
00613994686756 P980043 000
00613994686824 P980043 000
00613994686893 P980043 000
00613994686961 P980043 000
00643169027060 P980043 025
00643169000438 P980043 025
00643169000414 P980043 025
00643169000391 P980043 025
00643169000377 P980043 025
00643169000353 P980043 025
00643169000339 P980043 025
00643169000315 P980043 025
00643169000292 P980043 025
00643169000278 P980043 025
00643169000254 P980043 025
00643169027084 P980043 025
00643169027107 P980043 025
00643169027121 P980043 025
00613994772749 P980043 025
00613994772732 P980043 025
00613994772725 P980043 025
00613994772718 P980043 025
00613994760579 P980043 025
00613994760562 P980043 025
00613994760555 P980043 025
00613994760548 P980043 025
00613994760531 P980043 025
00613994772756 P980043 025
00643169027138 P980043 025
00643169534124 P980043 028
00643169534131 P980043 028
00643169534148 P980043 028
00643169534155 P980043 028
00643169534100 P980043 028
00643169534094 P980043 028
00643169534087 P980043 028
00643169534070 P980043 028
00643169534063 P980043 028
00643169534056 P980043 028
00643169534049 P980043 028
00643169534032 P980043 028
00643169534117 P980043 028
00643169594449 P980043 048
00643169594463 P980043 048
00643169594524 P980043 048
00643169594531 P980043 048
00643169594548 P980043 048
00643169594562 P980043 048
00643169594555 P980043 048
00643169594579 P980043 048
00643169594586 P980043 048
00643169594593 P980043 048
00643169594609 P980043 048
00643169594616 P980043 048
00643169594241 P980043 048
00643169594258 P980043 048
00643169594265 P980043 048
00643169594432 P980043 048
00643169594425 P980043 048
00643169594418 P980043 048
00643169594401 P980043 048
00643169594395 P980043 048
00643169594333 P980043 048
00643169594326 P980043 048
00643169594319 P980043 048
00643169594302 P980043 048
00643169594296 P980043 048
00643169594289 P980043 048
00643169594456 P980043 048
00643169594272 P980043 048

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.