PMA P950015S008
- Device
- HEART LASER 2 (HL2)
- Applicant
- Laser Engineering Heart, Inc.
- PMA number
- P950015
- Supplement
- S008
- Product code
- MNO
- Decision date
- 2001-01-29
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- 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.
Current openFDA PMA Record#
- Device
- HEART LASER 2 (HL2)
- Applicant
- Laser Engineering Heart, Inc.
- PMA number
- P950015
- Supplement
- S008
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2001-01-29
- Decision code
- APPR
- Date received
- 2000-09-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- 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.