WOLVERINE Coronary Cutting Balloon

Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring

FDA Premarket Approval P950020 S099

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

To reduce the ethylene oxide gas concentration and qualify additional process challenge devices used in the bsc2000-2 sterilization cycle

DeviceWOLVERINE Coronary Cutting Balloon
Classification NameCatheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring
Generic NameCatheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring
ApplicantBoston Scientific Corp.
Date Received2019-10-10
Decision Date2019-11-07
PMAP950020
SupplementS099
Product CodeNWX
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566

Supplemental Filings

Supplement NumberDateSupplement Type
P950020Original Filing
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

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