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 a manufacturing change to up-date the laser console portion of the device system from the currently approved hl1 (heart laser(tm)) to the hl2 (hear laser 2). The device, as modified, will be marketed under the trade name heart laser 2 (hl2), and is indicated for use in the treatment of patients with stable angina (canadian cardiovascular society class 3 or 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium not amenable to direct coronary revascularization.
| Device | HEART LASER 2 (HL2) |
| Classification Name | System, Laser, Transmyocardial Revascularization |
| Generic Name | System, Laser, Transmyocardial Revascularization |
| Applicant | Laser Engineering Heart Inc. |
| Date Received | 2000-09-28 |
| Decision Date | 2001-01-29 |
| PMA | P950015 |
| Supplement | S008 |
| Product Code | MNO |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |