PMA P970029S014
- Device
- CARDIOGENESIS HOLMIUM TMR SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S014
- Product code
- MNO
- Decision date
- 2012-02-22
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- APPROVAL FOR THE PEARL 8.0 HANDPIECE.
Current openFDA PMA Record#
- Device
- CARDIOGENESIS HOLMIUM TMR SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S014
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2012-02-22
- Decision code
- APPR
- Date received
- 2009-07-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE PEARL 8.0 HANDPIECE.