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 | ELCA Coronary Laser Catheters |
| Generic Name | Device, Angioplasty, Laser, Coronary |
| Applicant | SPECTRANETICS CORP.9965 Federal Drivecolorado Springs, CO 80921 PMA NumberP910001 Supplement NumberS117 Date Received09/23/2022 Decision Date10/21/2022 Product Code LPC Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-23 |
| Decision Date | 2022-10-21 |
| PMA | P910001 |
| Supplement | S117 |
| Product Code | LPC |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SPECTRANETICS CORP. 9965 Federal Drive colorado Springs, CO 80921 PMA NumberP910001 Supplement NumberS117 Date Received09/23/2022 Decision Date10/21/2022 Product Code LPC Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement elimination Of A Quality Control Test |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910001 | Original Filing | |
| S117 | 2022-09-23 | 30-day Notice |
| S116 | 2022-06-17 | Real-time Process |
| S115 | 2022-02-23 | Real-time Process |
| S114 | 2022-02-14 | Special (immediate Track) |
| S113 | 2021-03-03 | Real-time Process |
| S112 | ||
| S111 | 2020-10-19 | Real-time Process |
| S110 | 2019-09-27 | 30-day Notice |
| S109 | 2018-12-26 | 135 Review Track For 30-day Notice |
| S108 | 2018-10-22 | 30-day Notice |
| S107 | 2018-09-24 | 30-day Notice |
| S106 | 2018-08-30 | 30-day Notice |
| S105 | 2018-07-16 | 30-day Notice |
| S104 | 2018-04-09 | 30-day Notice |
| S103 | 2018-02-28 | 30-day Notice |
| S102 | 2017-11-28 | 30-day Notice |
| S101 | ||
| S100 | ||
| S099 | 2017-08-22 | 30-day Notice |
| S098 | 2017-08-04 | 30-day Notice |
| S097 | 2017-08-03 | Real-time Process |
| S096 | 2017-07-27 | 30-day Notice |
| S095 | 2017-07-24 | Special (immediate Track) |
| S094 | 2017-06-30 | Special (immediate Track) |
| S093 | 2017-05-22 | 30-day Notice |
| S092 | 2017-04-07 | Special (immediate Track) |
| S091 | 2017-03-09 | Real-time Process |
| S090 | 2016-12-08 | 30-day Notice |
| S089 | 2016-11-16 | Real-time Process |
| S088 | 2016-10-04 | 30-day Notice |
| S087 | 2016-06-08 | Special (immediate Track) |
| S086 | 2016-05-25 | 30-day Notice |
| S085 | 2016-03-14 | Special (immediate Track) |
| S084 | 2016-03-08 | 30-day Notice |
| S083 | 2016-01-13 | 30-day Notice |
| S082 | 2015-11-25 | 30-day Notice |
| S081 | 2015-11-09 | 30-day Notice |
| S080 | 2015-09-01 | 30-day Notice |
| S079 | 2015-08-28 | Normal 180 Day Track |
| S078 | 2015-07-22 | Real-time Process |
| S077 | 2015-01-12 | 30-day Notice |
| S076 | 2014-12-08 | 30-day Notice |
| S075 | 2014-12-08 | 30-day Notice |
| S074 | 2014-11-18 | 30-day Notice |
| S073 | 2014-08-11 | 30-day Notice |
| S072 | 2014-07-14 | Real-time Process |
| S071 | 2014-04-15 | Real-time Process |
| S070 | 2014-03-19 | 30-day Notice |
| S069 | 2013-12-17 | 30-day Notice |
| S068 | ||
| S067 | 2013-09-03 | 30-day Notice |
| S066 | 2013-07-22 | 30-day Notice |
| S065 | 2013-04-01 | Normal 180 Day Track |
| S064 | 2013-01-30 | 30-day Notice |
| S063 | 2012-12-11 | 30-day Notice |
| S062 | 2012-11-27 | 30-day Notice |
| S061 | 2012-08-01 | 30-day Notice |
| S060 | 2012-07-02 | 30-day Notice |
| S059 | 2012-07-02 | Normal 180 Day Track |
| S058 | 2012-06-25 | 30-day Notice |
| S057 | 2012-06-06 | 30-day Notice |
| S056 | 2012-05-08 | Real-time Process |
| S055 | 2012-05-01 | 30-day Notice |
| S054 | 2012-04-02 | 30-day Notice |
| S053 | 2012-01-27 | 30-day Notice |
| S052 | 2011-12-02 | 30-day Notice |
| S051 | 2011-11-30 | 135 Review Track For 30-day Notice |
| S050 | 2011-10-07 | Real-time Process |
| S049 | 2011-08-26 | Real-time Process |
| S048 | 2011-05-10 | 30-day Notice |
| S047 | 2011-05-09 | Normal 180 Day Track No User Fee |
| S046 | ||
| S045 | 2011-02-04 | 135 Review Track For 30-day Notice |
| S044 | 2011-02-01 | 30-day Notice |
| S043 | 2011-01-06 | 30-day Notice |
| S042 | 2011-01-03 | 135 Review Track For 30-day Notice |
| S041 | 2010-12-01 | 30-day Notice |
| S040 | 2010-11-22 | Normal 180 Day Track No User Fee |
| S039 | ||
| S038 | 2010-10-12 | 30-day Notice |
| S037 | 2010-09-15 | 30-day Notice |
| S036 | ||
| S035 | ||
| S034 | 2010-02-18 | Normal 180 Day Track No User Fee |
| S033 | 2009-09-11 | Normal 180 Day Track |
| S032 | 2009-06-02 | Real-time Process |
| S031 | 2009-05-05 | 30-day Notice |
| S030 | ||
| S029 | ||
| S028 | 2008-11-05 | 30-day Notice |
| S027 | 2008-10-30 | 135 Review Track For 30-day Notice |
| S026 | 2006-11-16 | Normal 180 Day Track |
| S025 | 2006-04-14 | Real-time Process |
| S024 | 2003-02-10 | Normal 180 Day Track |
| S023 | 2003-01-31 | Normal 180 Day Track No User Fee |
| S022 | ||
| S021 | 2002-09-05 | Normal 180 Day Track |
| S020 | 2001-03-30 | Normal 180 Day Track |
| S019 | 2000-12-21 | Normal 180 Day Track |
| S018 | 2000-02-09 | Normal 180 Day Track |
| S017 | 1999-09-28 | 135 Review Track For 30-day Notice |
| S016 | 1999-06-14 | Normal 180 Day Track |
| S015 | 1999-03-08 | Normal 180 Day Track |
| S014 | 1998-08-25 | Normal 180 Day Track |
| S013 | 1998-03-17 | Normal 180 Day Track |
| S012 | 1996-11-27 | Normal 180 Day Track |
| S011 | ||
| S010 | 1994-09-26 | Normal 180 Day Track |
| S009 | 1994-09-12 | Normal 180 Day Track |
| S008 | 1994-05-24 | Normal 180 Day Track |
| S007 | 1994-05-16 | Normal 180 Day Track |
| S006 | 1993-07-07 | Normal 180 Day Track |
| S005 | 1993-06-17 | Normal 180 Day Track |
| S004 | ||
| S003 | ||
| S002 | 1992-09-14 | Normal 180 Day Track |
| S001 | 1992-06-08 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| M204117205AA0 | P910001 | 000 |
| 00813132025427 | P910001 | 000 |
| M204120008AA0 | P910001 | 012 |
| 00813132025410 | P910001 | 012 |
| 00813132025441 | P910001 | 014 |
| 00813132025434 | P910001 | 014 |
| M204114009AA0 | P910001 | 014 |
| 00813132025403 | P910001 | 014 |
| M204120009AA0 | P910001 | 014 |
| M204117016AA0 | P910001 | 014 |
| M204110001AA0 | P910001 | 015 |
| M204110002AA0 | P910001 | 015 |
| 00813132025489 | P910001 | 015 |
| M204110003AA0 | P910001 | 018 |
| 00813132025465 | P910001 | 018 |
| 00813132025458 | P910001 | 019 |
| M204110004AA0 | P910001 | 019 |
| 00813132025472 | P910001 | 019 |
| 00813132029937 | P910001 | 033 |
| 00813132027452 | P910001 | 112 |