PMA P970029S028
- Device
- CARDIOGENESIS TMR SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S028
- Product code
- MNO
- Decision date
- 2015-12-22
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- APPROVAL OF UPDATES REGARDING FOREIGN MATERIAL INSPECTIONS, AND LEAK TESTING.
Current openFDA PMA Record#
- Device
- CARDIOGENESIS TMR SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S028
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2015-12-22
- Decision code
- APPR
- Date received
- 2015-12-11
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL OF UPDATES REGARDING FOREIGN MATERIAL INSPECTIONS, AND LEAK TESTING.