Approval for two specific additional quality control inspection steps during the manufacturing of the sologrip handpiece and the addition of specific language in three places to the instructions for use for the sologrip handpiece.
| Device | ECLIPSE TMR HOLMIUM LASER SYSTEM |
| Classification Name | System, Laser, Transmyocardial Revascularization |
| Generic Name | System, Laser, Transmyocardial Revascularization |
| Applicant | CRYOLIFE, INC. |
| Date Received | 2000-11-09 |
| Decision Date | 2000-12-08 |
| PMA | P970029 |
| Supplement | S005 |
| 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