This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for changes made to the labeling as a result of completion of the post-approval study.
| Device | THE HEART LASER CO2 TMR SYSTEM |
| Classification Name | System, Laser, Transmyocardial Revascularization |
| Generic Name | System, Laser, Transmyocardial Revascularization |
| Applicant | Laser Engineering Heart Inc. |
| Date Received | 2008-09-12 |
| Decision Date | 2009-03-08 |
| PMA | P950015 |
| Supplement | S011 |
| Product Code | MNO |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Laser Engineering Heart Inc. 475 Metroplex Drive, Suite 401 nashville, TN 37211 |
| 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 |