PMA P970029S011
- Device
- TMR2000 HOLMIUM LASER SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S011
- Product code
- MNO
- Decision date
- 2007-11-05
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- APPROVAL FOR PEARL 5.0 HANDPIECE.
Current openFDA PMA Record#
- Device
- TMR2000 HOLMIUM LASER SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S011
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2007-11-05
- Decision code
- APPR
- Date received
- 2007-05-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR PEARL 5.0 HANDPIECE.