Freestyle Bioprosthesis

FDA Premarket Approval P970031 S069

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 change in storage temperature requirements for the tissue fixation solution

DeviceFreestyle Bioprosthesis
Generic NameHeart-valve, Non-allograft Tissue
ApplicantMedtronic, Inc.
Date Received2020-11-19
Decision Date2020-12-16
PMAP970031
SupplementS069
Product CodeLWR 
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
P970031Original Filing
S069 2020-11-19 30-day Notice
S068
S067 2019-09-26 Real-time Process
S066 2019-06-20 30-day Notice
S065 2019-01-29 30-day Notice
S064
S063 2018-04-12 30-day Notice
S062 2017-12-20 30-day Notice
S061 2017-10-18 30-day Notice
S060
S059 2017-09-11 30-day Notice
S058 2017-08-14 135 Review Track For 30-day Notice
S057 2017-07-10 30-day Notice
S056 2017-02-22 30-day Notice
S055 2017-02-08 30-day Notice
S054 2016-11-10 Real-time Process
S053 2016-10-25 30-day Notice
S052 2016-05-06 30-day Notice
S051 2015-10-13 30-day Notice
S050 2015-09-21 Special (immediate Track)
S049 2014-11-07 30-day Notice
S048 2014-10-14 30-day Notice
S047 2014-08-05 30-day Notice
S046 2014-06-23 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 2012-11-19 30-day Notice
S036 2012-03-23 Normal 180 Day Track
S035 2011-08-17 30-day Notice
S034 2011-07-28 30-day Notice
S033
S032 2011-02-15 Real-time Process
S031 2010-10-21 30-day Notice
S030 2010-10-20 30-day Notice
S029 2010-04-30 30-day Notice
S028 2010-01-06 30-day Notice
S027 2010-01-06 135 Review Track For 30-day Notice
S026 2009-10-05 30-day Notice
S025 2009-07-09 30-day Notice
S024 2008-08-11 30-day Notice
S023 2008-07-11 30-day Notice
S022 2007-10-15 30-day Notice
S021
S020 2007-09-19 30-day Notice
S019 2007-07-02 135 Review Track For 30-day Notice
S018
S017 2006-08-03 30-day Notice
S016
S015 2006-03-27 Normal 180 Day Track No User Fee
S014 2005-12-27 135 Review Track For 30-day Notice
S013 2003-07-28 Normal 180 Day Track
S012
S011 2001-06-01 Normal 180 Day Track
S010 2001-05-03 Normal 180 Day Track
S009 1999-08-30 Normal 180 Day Track
S008 1999-08-04 Normal 180 Day Track
S007 1998-10-02 30-day Notice
S006 1998-04-06 Normal 180 Day Track
S005 1998-02-11 Normal 180 Day Track
S004 1998-01-12 Normal 180 Day Track
S003 1997-12-24 Normal 180 Day Track
S002
S001

NIH GUDID Devices

Device IDPMASupp
00643169002098 P970031 000
00643169002135 P970031 000
00643169002111 P970031 000
00643169002098 P970031 000
00613994348975 P970031 000
00643169008137 P970031 000
00681490265942 P970031 000
00681490265904 P970031 000
00681490265898 P970031 000
00681490265898 P970031 000
00681490265904 P970031 000
00681490265942 P970031 000
00643169002159 P970031 000
00643169002173 P970031 000
00613994348975 P970031 000
00643169002111 P970031 000
00643169002159 P970031 000
00643169008137 P970031 000
00643169002135 P970031 000
00643169002173 P970031 000
00681490219198 P970031 008
00681490219150 P970031 008
00643169002227 P970031 008
00681490219112 P970031 008
00681490219075 P970031 008
00681490219037 P970031 008
00643169002241 P970031 008
00643169002265 P970031 008
00643169002289 P970031 008
00643169002302 P970031 008
00681490219112 P970031 008
00643169002302 P970031 008
00643169002265 P970031 008
00681490219037 P970031 008
00681490219075 P970031 008
00643169002227 P970031 008
00643169002241 P970031 008
00681490219150 P970031 008
00681490219198 P970031 008
00643169002289 P970031 008
00643169002395 P970031 010
00721902316142 P970031 010
00643169002012 P970031 010
00643169002395 P970031 010
00643169002050 P970031 010
00643169002418 P970031 010
00643169002418 P970031 010
00643169002050 P970031 010
00643169002036 P970031 010
00643169002036 P970031 010
00643169002012 P970031 010
00721902316180 P970031 010
00721902316173 P970031 010
00721902316166 P970031 010
00721902316159 P970031 010
00721902316142 P970031 010
00721902316180 P970031 010
00721902316173 P970031 010
00721902316166 P970031 010
00721902316159 P970031 010
00643169002197 P970031 011
00613994348982 P970031 011
00681490816465 P970031 011
00643169008144 P970031 011
00643169008144 P970031 011
00643169002197 P970031 011
00681490816465 P970031 011
00613994348982 P970031 011
00643169002074 P970031 013
00721902316197 P970031 013
00721902316197 P970031 013
00643169002074 P970031 013

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.