PMA P950015S001
- Device
- THE HEART LASER CO2 TMR SYSTEM
- Applicant
- Laser Engineering Heart, Inc.
- PMA number
- P950015
- Supplement
- S001
- Product code
- MNO
- Decision date
- 1998-10-06
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- Approval for the post approval clinical study to be conducted as a condition of approval.
Current openFDA PMA Record#
- Device
- THE HEART LASER CO2 TMR SYSTEM
- Applicant
- Laser Engineering Heart, Inc.
- PMA number
- P950015
- Supplement
- S001
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 1998-10-06
- Decision code
- APPR
- Date received
- 1998-09-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the post approval clinical study to be conducted as a condition of approval.