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 the post approval clinical study to be conducted as a condition of approval.
| 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 | 1998-09-21 |
| Decision Date | 1998-10-06 |
| PMA | P950015 |
| Supplement | S001 |
| Product Code | MNO |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| 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 |