Addition of a vent hood to the main manufacturing clean room wicking stations.
| Device | SLS ll/GlideLight Catheters |
| Classification Name | Device, Removal, Pacemaker Electrode, Percutaneous |
| Generic Name | Device, Removal, Pacemaker Electrode, Percutaneous |
| Applicant | SPECTRANETICS CORP. |
| Date Received | 2018-07-16 |
| Decision Date | 2018-08-14 |
| PMA | P960042 |
| Supplement | S063 |
| Product Code | MFA |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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