This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the heart laser co2 tmr system. This device is indicated for the treatment of patients with stable angina (canadian cardiovascular society class 3 or 4) refractory to medical treatment and secondary to objectively demonstarted coronary artery atherosclerosis not amenable to direct coronary revascularization.
| Device | THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION |
| Classification Name | System, Laser, Transmyocardial Revascularization |
| Generic Name | System, Laser, Transmyocardial Revascularization |
| Applicant | Laser Engineering Heart Inc. |
| Date Received | 1995-04-18 |
| Decision Date | 1998-08-20 |
| Notice Date | 1999-08-17 |
| PMA | P950015 |
| Supplement | S |
| Product Code | MNO |
| Docket Number | 99M-2672 |
| Advisory Committee | Cardiovascular |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | Laser Engineering Heart Inc. 475 Metroplex Drive, Suite 401 nashville, TN 37211 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950015 | Original Filing | |
| S012 | 2013-10-07 | Normal 180 Day Track No User Fee |
| S011 | 2008-09-12 | Normal 180 Day Track No User Fee |
| S010 | 2004-07-06 | Normal 180 Day Track |
| S009 | ||
| S008 | 2000-09-28 | Normal 180 Day Track |
| S007 | 2000-09-12 | Real-time Process |
| S006 | 1999-11-24 | Special (immediate Track) |
| S005 | 1999-06-28 | Normal 180 Day Track |
| S004 | ||
| S003 | 1999-05-14 | Normal 180 Day Track |
| S002 | 1999-03-29 | Special (immediate Track) |
| S001 | 1998-09-21 | Normal 180 Day Track |