Approval for changing the device’s labeling, specifically, the wording of a precaution statement in the instructions for use.
| Device | ELCA Coronary Atherectomy Catheter |
| Generic Name | Device, Angioplasty, Laser, Coronary |
| Applicant | SPECTRANETICS CORP. |
| Date Received | 2021-03-03 |
| Decision Date | 2021-05-11 |
| PMA | P910001 |
| Supplement | S113 |
| Product Code | LPC |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SPECTRANETICS CORP. 9965 Federal Drive colorado Springs, CO 80921 |
Supplemental Filings
| 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 |
NIH GUDID Devices