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.
| Device | WOLVERINE Coronary Cutting Balloon |
| Generic Name | Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring |
| Applicant | Boston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP950020 Supplement NumberS118 Date Received03/03/2022 Decision Date03/31/2022 Product Code NWX Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-03 |
| Decision Date | 2022-03-31 |
| PMA | P950020 |
| Supplement | S118 |
| Product Code | NWX |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566 PMA NumberP950020 Supplement NumberS118 Date Received03/03/2022 Decision Date03/31/2022 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 Galway, Ireland As An Additional Manufacturing Site For The WOLVERINE Monorail (MR) And Over The Wire (OTW) Distal Outer (monorail Only), Distal Inner, Proximal Inner And Bumper Tip Components |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950020 | Original Filing | |
| S134 | 2023-01-10 | 30-day Notice |
| S133 | ||
| S132 | 2022-12-02 | 30-day Notice |
| S131 | 2022-11-15 | 30-day Notice |
| S130 | ||
| S129 | 2022-10-25 | 30-day Notice |
| S128 | ||
| S127 | 2022-10-11 | 30-day Notice |
| S126 | 2022-09-19 | 30-day Notice |
| S125 | 2022-09-06 | 30-day Notice |
| 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 |