PMA P970029S034
- Device
- TMR Holmium Laser System
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S034
- Product code
- MNO
- Decision date
- 2017-08-31
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- Approval for modifications to the high voltage power supply.
Current openFDA PMA Record#
- Device
- TMR Holmium Laser System
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S034
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2017-08-31
- Decision code
- APPR
- Date received
- 2017-06-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modifications to the high voltage power supply.