Modification to the ethylene oxide sterilization cycle.
Device | SLS SPECTRANETICS LASER SHEATHS |
Classification Name | Device, Removal, Pacemaker Electrode, Percutaneous |
Generic Name | Device, Removal, Pacemaker Electrode, Percutaneous |
Applicant | SPECTRANETICS CORP. |
Date Received | 2012-04-02 |
Decision Date | 2012-05-02 |
PMA | P960042 |
Supplement | S035 |
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