PMA P970029S033
- Device
- CardioGenesis TMR System
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S033
- Product code
- MNO
- Decision date
- 2017-08-07
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- Approval for a change in material used in the construction of the Handpieces.
Current openFDA PMA Record#
- Device
- CardioGenesis TMR System
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S033
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2017-08-07
- Decision code
- APPR
- Date received
- 2017-05-10
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in material used in the construction of the Handpieces.