Approval for a change to an adhesive primer used in the manufacture of the elca eccentric (ell) devices. Previously, you have used loctite 793 which has been discontinued by the vendor. The primer has been changed to loctite 7701, a medical grade adhesive primer used for the same purpose.
| Device | EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER |
| Classification Name | Device, Angioplasty, Laser, Coronary |
| Generic Name | Device, Angioplasty, Laser, Coronary |
| Applicant | SPECTRANETICS CORP. |
| Date Received | 2012-07-02 |
| Decision Date | 2013-04-04 |
| PMA | P910001 |
| Supplement | S059 |
| Product Code | LPC |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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