Approval for modification of an existing warning statement to state: ¿each handpiece delivery sytem is supplied sterile for single use only. Do not reuse or resterilize. Any attempt to clean and resterilize can damage the fiberoptic. ¿
| Device | CARDIOGENESIS TMR 2000 HOLMIUM LASER SYSTEM |
| Classification Name | System, Laser, Transmyocardial Revascularization |
| Generic Name | System, Laser, Transmyocardial Revascularization |
| Applicant | CRYOLIFE, INC. |
| Date Received | 2010-03-19 |
| Decision Date | 2010-04-15 |
| PMA | P970029 |
| Supplement | S017 |
| Product Code | MNO |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |
NIH GUDID Devices