PMA P970029S029
- Device
- TMR HOLMIUM LASER SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S029
- Product code
- MNO
- Decision date
- 2016-06-21
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- Change to the frequency of the bioburden assessments, from quarterly to annually, for the SoloGrip III and PEARL 5.0 Handpieces.
Current openFDA PMA Record#
- Device
- TMR HOLMIUM LASER SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S029
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2016-06-21
- Decision code
- OK30
- Date received
- 2016-05-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the frequency of the bioburden assessments, from quarterly to annually, for the SoloGrip III and PEARL 5.0 Handpieces.