Approval for the 14 french (fr. ) and 16 fr. Laser sheath kits and individually packaged accessory devices (14 fr. And 16 fr. Outer sheaths and fish tape). The laser sheath kits include: one laser sheath (14 fr. Or 16 fr. ), two outer sheaths (14 fr. Or 16 fr. ), and a fish tape. The laser sheath kits, as modified, will be marketed under the trade names 14 fr. And 16 fr. Laser sheath kits and are indicated for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.
| Device | 14 FR. AND 16 FR. LASER SHEATH KIT AND FISH TAPE |
| Applicant | SPECTRANETICS CORP. |
| Date Received | 1998-03-09 |
| Decision Date | 1998-09-04 |
| PMA | P960042 |
| Supplement | S002 |
| 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 |
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