PMA P950015S002
- Device
- THE HEART LASER CO2 TMR SYSTEM
- Applicant
- Laser Engineering Heart, Inc.
- PMA number
- P950015
- Supplement
- S002
- Product code
- MNO
- Decision date
- 1999-04-27
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- Approval for changes to the labeling.
Current openFDA PMA Record#
- Device
- THE HEART LASER CO2 TMR SYSTEM
- Applicant
- Laser Engineering Heart, Inc.
- PMA number
- P950015
- Supplement
- S002
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 1999-04-27
- Decision code
- APPR
- Date received
- 1999-03-29
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the labeling.