PMA P970029S018
- Device
- CARDIOGENESIS TMR SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S018
- Product code
- MNO
- Decision date
- 2011-12-16
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- CHANGES TO THE MANUFACTURING OF THE HANDPIECE DELIVERY SYSTEM.
Current openFDA PMA Record#
- Device
- CARDIOGENESIS TMR SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S018
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2011-12-16
- Decision code
- OK30
- Date received
- 2011-11-17
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGES TO THE MANUFACTURING OF THE HANDPIECE DELIVERY SYSTEM.