PMA P950015S011
- Device
- THE HEART LASER CO2 TMR SYSTEM
- Applicant
- Laser Engineering Heart, Inc.
- PMA number
- P950015
- Supplement
- S011
- Product code
- MNO
- Decision date
- 2009-03-08
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- APPROVAL FOR CHANGES MADE TO THE LABELING AS A RESULT OF COMPLETION OF THE POST-APPROVAL STUDY.
Current openFDA PMA Record#
- Device
- THE HEART LASER CO2 TMR SYSTEM
- Applicant
- Laser Engineering Heart, Inc.
- PMA number
- P950015
- Supplement
- S011
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2009-03-08
- Decision code
- APPR
- Date received
- 2008-09-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR CHANGES MADE TO THE LABELING AS A RESULT OF COMPLETION OF THE POST-APPROVAL STUDY.