PMA P950015S005
- Device
- THE HEART LASER-TM CO2 TMR SYSTEM (THE HEART LASER)
- Applicant
- Laser Engineering Heart, Inc.
- PMA number
- P950015
- Supplement
- S005
- Product code
- MNO
- Decision date
- 2000-03-08
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- Approval for specific software revisions addressed to disarming the laser after it has fired and to resolving a minor Y2K problem.
Current openFDA PMA Record#
- Device
- THE HEART LASER-TM CO2 TMR SYSTEM (THE HEART LASER)
- Applicant
- Laser Engineering Heart, Inc.
- PMA number
- P950015
- Supplement
- S005
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2000-03-08
- Decision code
- APPR
- Date received
- 1999-06-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for specific software revisions addressed to disarming the laser after it has fired and to resolving a minor Y2K problem.