PMA P970029S022
- Device
- PEARL 8.0 HANDPIECE FOR TRANSMYOCARDIAL REVASCULARIZATION (TMR) WITH THE CARDIOGENESIS HOLMIUM: YAG LASER SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S022
- Product code
- MNO
- Decision date
- 2012-12-18
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- PEARL 8.0 HANDPIECE FOR TRANSMYOCARDIAL REVASCULARIZATION (TMR) WITH THE CARDIOGENESIS HOLMIUM: YAG LASER SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S022
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2012-12-18
- Decision code
- APPR
- Date received
- 2012-10-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.