Approval for the eclipse tmr holmium laser system. Transmyocardial revascularization with the eclipse tmr system is indicated for treatment of stable patients with angina (canadian cardiovascular society class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium iwth reversible ischemia not amendable to direct coronary revascularization.
| Device | TMR HOLMIUM LASER SYSTEM |
| Classification Name | System, Laser, Transmyocardial Revascularization |
| Generic Name | System, Laser, Transmyocardial Revascularization |
| Applicant | CRYOLIFE, INC. |
| Date Received | 1997-07-02 |
| Decision Date | 1999-02-11 |
| Notice Date | 1999-07-19 |
| PMA | P970029 |
| Supplement | S |
| Product Code | MNO |
| Docket Number | 99M-2238 |
| Advisory Committee | Cardiovascular |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | CRYOLIFE, INC. 1655 Roberts Blvd., N.w. kennesaw, GA 30144 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
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 |
NIH GUDID Devices