Approval for the solargen 2100s laser to replace the tmr2000 laser in the cardiogenesis tmr holmium laser system. The solargen 2100s will be manufactured by new star lasers, inc. Of roseville, california.
| Device | SOLARGEN 2100S LASER |
| Classification Name | System, Laser, Transmyocardial Revascularization |
| Generic Name | System, Laser, Transmyocardial Revascularization |
| Applicant | CRYOLIFE, INC. |
| Date Received | 2004-03-24 |
| Decision Date | 2004-12-23 |
| PMA | P970029 |
| Supplement | S009 |
| Product Code | MNO |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CRYOLIFE, INC. 1655 Roberts Blvd., N.w. kennesaw, GA 30144 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P970029 | | Original Filing |
| S040 |
2022-08-04 |
Special (immediate Track) |
| S039 |
2019-04-18 |
30-day Notice |
| S038 | | |
| S037 |
2018-06-12 |
30-day Notice |
| S036 |
2017-08-14 |
30-day Notice |
| S035 |
2017-06-29 |
30-day Notice |
| S034 |
2017-06-09 |
Real-time Process |
| S033 |
2017-05-10 |
Normal 180 Day Track |
| S032 |
2016-08-12 |
Special (immediate Track) |
| S031 | | |
| S030 |
2016-05-25 |
30-day Notice |
| S029 |
2016-05-25 |
30-day Notice |
| S028 |
2015-12-11 |
Special (immediate Track) |
| S027 |
2015-02-13 |
Normal 180 Day Track No User Fee |
| S026 |
2014-04-09 |
Special (immediate Track) |
| S025 |
2013-11-26 |
Normal 180 Day Track No User Fee |
| S024 |
2013-01-29 |
Real-time Process |
| S023 | | |
| S022 |
2012-10-19 |
Normal 180 Day Track No User Fee |
| S021 |
2012-08-16 |
Special (immediate Track) |
| S020 |
2012-06-27 |
Special (immediate Track) |
| S019 |
2012-03-27 |
Normal 180 Day Track No User Fee |
| S018 |
2011-11-17 |
30-day Notice |
| S017 |
2010-03-19 |
Special (immediate Track) |
| S016 | | |
| S015 |
2009-08-31 |
Normal 180 Day Track No User Fee |
| S014 |
2009-07-30 |
Normal 180 Day Track |
| S013 |
2008-10-22 |
Normal 180 Day Track No User Fee |
| S012 |
2008-08-15 |
Special (immediate Track) |
| S011 |
2007-05-09 |
Normal 180 Day Track |
| S010 | | |
| S009 |
2004-03-24 |
Normal 180 Day Track |
| S008 |
2001-10-05 |
Normal 180 Day Track |
| S007 |
2001-05-25 |
Special (immediate Track) |
| S006 |
2001-01-24 |
Normal 180 Day Track |
| S005 |
2000-11-09 |
Special (immediate Track) |
| S004 | | |
| S003 |
1999-12-06 |
Special (immediate Track) |
| S002 | | |
| S001 |
1999-03-26 |
Normal 180 Day Track |
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