Approval for the 12 french laser sheath kit which consists of the 12 french laser sheath (model 500-001) and fish tape accessory. The device is 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 | SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH |
| Classification Name | Device, Removal, Pacemaker Electrode, Percutaneous |
| Generic Name | Device, Removal, Pacemaker Electrode, Percutaneous |
| Applicant | SPECTRANETICS CORP. |
| Date Received | 1996-11-26 |
| Decision Date | 1997-12-09 |
| Notice Date | 1998-07-14 |
| PMA | P960042 |
| Supplement | S |
| Product Code | MFA |
| Docket Number | 98M-0451 |
| Advisory Committee | Cardiovascular |
| Expedited Review | Yes |
| 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