PMA P950015S010
- Device
- THE HEART LASER CO2 TMR SYSTEM
- Applicant
- Laser Engineering Heart, Inc.
- PMA number
- P950015
- Supplement
- S010
- Product code
- MNO
- Decision date
- 2005-03-21
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE ELECTRONIC PRE-IGNITION SYSTEM USED BY THE LASER MEDICAL DEVICE.
Current openFDA PMA Record#
- Device
- THE HEART LASER CO2 TMR SYSTEM
- Applicant
- Laser Engineering Heart, Inc.
- PMA number
- P950015
- Supplement
- S010
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2005-03-21
- Decision code
- APPR
- Date received
- 2004-07-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE ELECTRONIC PRE-IGNITION SYSTEM USED BY THE LASER MEDICAL DEVICE.