PMA P970029S032
- Device
- CARDIOGENESIS TMR LASER SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S032
- Product code
- MNO
- Decision date
- 2016-08-23
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- Approval for labeling changes to enhance the safety of CardioGenesis® TMR Laser System.
Current openFDA PMA Record#
- Device
- CARDIOGENESIS TMR LASER SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S032
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2016-08-23
- Decision code
- APPR
- Date received
- 2016-08-12
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes to enhance the safety of CardioGenesis® TMR Laser System.