PMA P970029S024
- Device
- CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S024
- Product code
- MNO
- Decision date
- 2013-05-31
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- APPROVAL FOR DESIGN CHANGES TO THE DISTAL FIBERS OF THE THREE HAND-PIECE MODELS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TMR2000 HOLMIUM LASER SYSTEM AND IS INDICATED FOR TRANS-MYOCARDIAL REVASCULARIZATION IN PATIENTS WITH ANGINA REFRACTORY TO MEDICAL TREATMENT AND SECONDARY TO OBJECTIVELY DEMONSTRATED CORONARY ARTERY ATHEROSCLEROSIS AND WITH A REGION OF THE MYOCARDIUM WITH REVERSIBLE ISCHEMIA NOT AMENABLE TO DIRECT CORONARY REVASCULARIZATION.
Current openFDA PMA Record#
- Device
- CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S024
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2013-05-31
- Decision code
- APPR
- Date received
- 2013-01-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR DESIGN CHANGES TO THE DISTAL FIBERS OF THE THREE HAND-PIECE MODELS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TMR2000 HOLMIUM LASER SYSTEM AND IS INDICATED FOR TRANS-MYOCARDIAL REVASCULARIZATION IN PATIENTS WITH ANGINA REFRACTORY TO MEDICAL TREATMENT AND SECONDARY TO OBJECTIVELY DEMONSTRATED CORONARY ARTERY ATHEROSCLEROSIS AND WITH A REGION OF THE MYOCARDIUM WITH REVERSIBLE ISCHEMIA NOT AMENABLE TO DIRECT CORONARY REVASCULARIZATION.