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 new study protocol, having both an accelerated aging and a real time aging arm, to demonstrate a two year shelf life for the tmr disposable kit (an accessory for the heart laser(tm) system). In addition, approval is requested to extend the shelf life for the tmr disposable kit from one year to two years, based on results of the accelerated aging portion of the proposed new protocol.
| Device | HEART LASER CO2 TMR SYSTEM |
| Classification Name | System, Laser, Transmyocardial Revascularization |
| Generic Name | System, Laser, Transmyocardial Revascularization |
| Applicant | Laser Engineering Heart Inc. |
| Date Received | 1999-05-14 |
| Decision Date | 1999-11-10 |
| PMA | P950015 |
| Supplement | S003 |
| Product Code | MNO |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |