WOLVERINE™ Coronary Cutting Balloon®

FDA Premarket Approval P950020 S123

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

DeviceWOLVERINE™ Coronary Cutting Balloon®
Generic NameCatheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring
ApplicantBoston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP950020 Supplement NumberS123 Date Received06/17/2022 Decision Date07/13/2022 Product Code NWX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-06-17
Decision Date2022-07-13
PMAP950020
SupplementS123
Product CodeNWX 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressBoston Scientific Corp.
one Scimed Place
maple Grove, MN 55311-1566 PMA NumberP950020 Supplement NumberS123 Date Received06/17/2022 Decision Date07/13/2022 Product Code NWX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
to Add An Additional Plasma And Blade Bonding Cell

Supplemental Filings

Supplement NumberDateSupplement Type
P950020Original Filing
S124 2022-07-11 30-day Notice
S123 2022-06-17 30-day Notice
S122 2022-04-29 30-day Notice
S121
S120 2022-03-14 30-day Notice
S119
S118 2022-03-03 30-day Notice
S117 2022-02-11 30-day Notice
S116 2022-01-28 30-day Notice
S115 2021-11-22 30-day Notice
S114 2021-11-15 30-day Notice
S113 2021-08-24 30-day Notice
S112
S111 2020-11-19 30-day Notice
S110 2020-11-12 30-day Notice
S109 2020-08-25 30-day Notice
S108 2020-06-09 30-day Notice
S107 2020-03-30 30-day Notice
S106
S105 2020-02-27 30-day Notice
S104 2020-02-05 30-day Notice
S103 2020-02-05 30-day Notice
S102 2020-01-28 30-day Notice
S101 2020-01-23 30-day Notice
S100 2019-12-13 30-day Notice
S099 2019-10-10 30-day Notice
S098 2019-06-27 30-day Notice
S097
S096 2019-03-12 30-day Notice
S095 2019-02-07 30-day Notice
S094 2019-02-01 30-day Notice
S093 2019-01-23 30-day Notice
S092 2018-11-16 30-day Notice
S091 2018-10-05 30-day Notice
S090 2018-08-17 30-day Notice
S089 2018-02-16 30-day Notice
S088 2018-01-09 30-day Notice
S087 2017-10-17 30-day Notice
S086 2017-10-16 30-day Notice
S085
S084 2017-09-29 30-day Notice
S083 2017-08-08 30-day Notice
S082 2017-08-04 30-day Notice
S081 2017-07-20 30-day Notice
S080 2017-04-11 30-day Notice
S079 2016-11-30 Normal 180 Day Track No User Fee
S078 2016-11-22 30-day Notice
S077 2016-11-17 30-day Notice
S076 2016-11-02 30-day Notice
S075 2016-09-01 30-day Notice
S074
S073 2016-05-12 30-day Notice
S072 2016-01-29 Normal 180 Day Track
S071 2015-01-07 30-day Notice
S070
S069 2014-08-26 30-day Notice
S068 2014-07-31 30-day Notice
S067 2014-01-17 30-day Notice
S066 2013-11-26 30-day Notice
S065 2013-09-20 30-day Notice
S064 2013-08-29 30-day Notice
S063 2013-06-10 30-day Notice
S062
S061 2013-03-29 Real-time Process
S060 2013-01-14 30-day Notice
S059 2012-11-19 30-day Notice
S058 2012-11-15 30-day Notice
S057 2012-11-13 30-day Notice
S056 2012-10-17 30-day Notice
S055 2012-10-10 Normal 180 Day Track
S054 2012-09-05 30-day Notice
S053 2012-08-16 30-day Notice
S052 2012-08-13 30-day Notice
S051 2012-06-14 30-day Notice
S050 2012-05-21 30-day Notice
S049 2012-02-29 30-day Notice
S048 2011-12-13 135 Review Track For 30-day Notice
S047 2011-11-04 30-day Notice
S046 2011-07-05 30-day Notice
S045 2011-06-21 30-day Notice
S044 2011-06-01 30-day Notice
S043
S042 2010-12-22 135 Review Track For 30-day Notice
S041
S040 2010-04-08 135 Review Track For 30-day Notice
S039 2010-03-12 30-day Notice
S038 2010-01-26 30-day Notice
S037 2010-01-26 30-day Notice
S036 2009-11-12 Normal 180 Day Track No User Fee
S035 2009-10-01 135 Review Track For 30-day Notice
S034 2009-08-31 30-day Notice
S033
S032 2009-03-03 Normal 180 Day Track No User Fee
S031 2008-12-17 30-day Notice
S030 2008-09-05 30-day Notice
S029 2008-05-19 30-day Notice
S028
S027 2008-05-05 30-day Notice
S026 2008-02-19 30-day Notice
S025 2007-01-24 30-day Notice
S024 2007-01-03 30-day Notice
S023 2006-12-07 135 Review Track For 30-day Notice
S022 2006-11-17 30-day Notice
S021 2006-11-07 30-day Notice
S020 2006-10-17 30-day Notice
S019 2006-09-19 30-day Notice
S018 2006-07-24 30-day Notice
S017 2006-06-02 Special (immediate Track)
S016 2006-05-09 30-day Notice
S015 2005-11-22 Normal 180 Day Track No User Fee
S014 2005-10-28 Normal 180 Day Track No User Fee
S013 2005-09-12 Normal 180 Day Track No User Fee
S012 2004-11-08 Normal 180 Day Track No User Fee
S011 2004-10-19 Normal 180 Day Track No User Fee
S010 2004-09-13 Normal 180 Day Track
S009 2003-12-08 30-day Notice
S008 2003-03-21 Real-time Process
S007 2002-11-01 Normal 180 Day Track
S006 2002-06-28 Normal 180 Day Track
S005 2002-05-22 Normal 180 Day Track
S004 2001-09-17 Normal 180 Day Track
S003 2001-08-20 Normal 180 Day Track
S002 2001-04-06 Normal 180 Day Track
S001 2000-10-17 Real-time Process

NIH GUDID Devices

Device IDPMASupp
08714729887867 P950020 072
08714729888017 P950020 072
08714729888024 P950020 072
08714729888031 P950020 072
08714729888048 P950020 072
08714729888055 P950020 072
08714729888062 P950020 072
08714729888079 P950020 072
08714729888093 P950020 072
08714729888109 P950020 072
08714729888116 P950020 072
08714729888123 P950020 072
08714729888000 P950020 072
08714729887997 P950020 072
08714729887980 P950020 072
08714729887874 P950020 072
08714729887881 P950020 072
08714729887898 P950020 072
08714729887904 P950020 072
08714729887911 P950020 072
08714729887928 P950020 072
08714729887935 P950020 072
08714729887942 P950020 072
08714729887959 P950020 072
08714729887966 P950020 072
08714729887973 P950020 072
08714729888130 P950020 072
08714729888147 P950020 072
08714729888291 P950020 072
08714729888307 P950020 072
08714729888314 P950020 072
08714729888321 P950020 072
08714729888338 P950020 072
08714729888345 P950020 072
08714729888352 P950020 072
08714729888369 P950020 072
08714729888376 P950020 072
08714729888383 P950020 072
08714729888390 P950020 072
08714729888284 P950020 072
08714729888277 P950020 072
08714729888260 P950020 072
08714729888154 P950020 072
08714729888161 P950020 072
08714729888178 P950020 072
08714729888185 P950020 072
08714729888192 P950020 072
08714729888208 P950020 072
08714729888215 P950020 072
08714729888222 P950020 072
08714729888239 P950020 072
08714729888246 P950020 072
08714729888253 P950020 072
08714729888673 P950020 072

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