|
Device | THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION |
Generic Name | SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION |
Applicant | Laser Engineering Heart Inc. 475 Metroplex Drive, Suite 401 Nashville, TN 37211 |
PMA Number | P950015 |
Date Received | 04/18/1995 |
Decision Date | 08/20/1998 |
Withdrawal Date
|
11/06/2020 |
Product Code |
MNO |
Docket Number | 99M-2672 |
Notice Date | 08/17/1999 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | Yes |
Combination Product | No |
Approval Order Statement 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S005 S006 S007 S008 S010 S011 S012 |