Approval for an increase in the maximum repetition rate from 40 hz to 80 hz of the spectranetics laser sheath. The device, as modified, will be marketed under the trade name glidelight laser sheath.
| Device | SPECTRANETICS LASER SHEATH DEVICE |
| Classification Name | Device, Removal, Pacemaker Electrode, Percutaneous |
| Generic Name | Device, Removal, Pacemaker Electrode, Percutaneous |
| Applicant | SPECTRANETICS CORP. |
| Date Received | 2011-09-06 |
| Decision Date | 2012-04-20 |
| PMA | P960042 |
| Supplement | S031 |
| Product Code | MFA |
| 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. 96 Talamine Ct. colorado Springs, CO 80907-5159 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P960042 | | Original Filing |
| S070 |
2021-01-25 |
Normal 180 Day Track |
| S069 |
2020-04-06 |
30-day Notice |
| S068 |
2019-09-27 |
30-day Notice |
| S067 |
2019-09-09 |
30-day Notice |
| S066 |
2019-06-07 |
30-day Notice |
| S065 |
2018-10-22 |
30-day Notice |
| S064 |
2018-09-24 |
30-day Notice |
| S063 |
2018-07-16 |
30-day Notice |
| S062 |
2018-06-08 |
Special (immediate Track) |
| S061 |
2018-05-01 |
30-day Notice |
| S060 |
2018-04-09 |
30-day Notice |
| S059 |
2017-07-18 |
30-day Notice |
| S058 |
2017-06-30 |
Special (immediate Track) |
| S057 |
2017-04-10 |
30-day Notice |
| S056 |
2017-04-07 |
Special (immediate Track) |
| S055 |
2016-12-08 |
30-day Notice |
| S054 |
2016-05-25 |
30-day Notice |
| S053 |
2016-03-14 |
Special (immediate Track) |
| S052 |
2015-11-09 |
30-day Notice |
| S051 |
2014-12-08 |
30-day Notice |
| S050 |
2014-10-01 |
30-day Notice |
| S049 |
2014-07-14 |
Real-time Process |
| S048 |
2014-03-19 |
30-day Notice |
| S047 |
2013-12-17 |
30-day Notice |
| S046 |
2013-01-30 |
30-day Notice |
| S045 |
2012-11-27 |
30-day Notice |
| S044 | | |
| S043 |
2012-11-07 |
Normal 180 Day Track |
| S042 |
2012-10-01 |
Special (immediate Track) |
| S041 |
2012-08-01 |
30-day Notice |
| S040 |
2012-07-02 |
30-day Notice |
| S039 |
2012-06-25 |
30-day Notice |
| S038 |
2012-05-01 |
30-day Notice |
| S037 |
2012-04-10 |
Real-time Process |
| S036 |
2012-04-05 |
Real-time Process |
| S035 |
2012-04-02 |
30-day Notice |
| S034 |
2012-01-27 |
30-day Notice |
| S033 |
2011-12-02 |
30-day Notice |
| S032 |
2011-11-30 |
135 Review Track For 30-day Notice |
| S031 |
2011-09-06 |
Normal 180 Day Track |
| S030 |
2011-05-10 |
30-day Notice |
| S029 |
2011-05-09 |
Normal 180 Day Track No User Fee |
| S028 |
2011-02-07 |
30-day Notice |
| S027 |
2011-02-04 |
135 Review Track For 30-day Notice |
| S026 |
2011-02-01 |
30-day Notice |
| S025 |
2011-01-10 |
30-day Notice |
| S024 | | |
| S023 |
2010-11-22 |
Normal 180 Day Track No User Fee |
| S022 |
2010-10-12 |
30-day Notice |
| S021 |
2010-08-16 |
30-day Notice |
| S020 |
2010-08-16 |
30-day Notice |
| S019 |
2010-08-02 |
30-day Notice |
| S018 | | |
| S017 |
2010-06-15 |
30-day Notice |
| S016 | | |
| S015 | | |
| S014 |
2009-06-02 |
Real-time Process |
| S013 |
2009-05-05 |
30-day Notice |
| S012 |
2009-04-01 |
Normal 180 Day Track No User Fee |
| S011 | | |
| S010 |
2008-10-30 |
135 Review Track For 30-day Notice |
| S009 |
2006-04-14 |
Real-time Process |
| S008 |
2002-01-17 |
Normal 180 Day Track |
| S007 |
2001-07-26 |
Normal 180 Day Track |
| S006 |
2000-08-11 |
Normal 180 Day Track |
| S005 |
1999-09-28 |
135 Review Track For 30-day Notice |
| S004 |
1999-02-17 |
Normal 180 Day Track |
| S003 |
1998-08-14 |
Normal 180 Day Track |
| S002 |
1998-03-09 |
Normal 180 Day Track |
| S001 |
1997-12-12 |
Normal 180 Day Track |
NIH GUDID Devices