PMA P970029S030
- Device
- TMR HOLMIUM LASER SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S030
- Product code
- MNO
- Decision date
- 2016-06-23
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- Adding an incoming visual inspection to be conducted after sterilization and before shipping of the laser handpieces.
Current openFDA PMA Record#
- Device
- TMR HOLMIUM LASER SYSTEM
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S030
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2016-06-23
- Decision code
- OK30
- Date received
- 2016-05-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding an incoming visual inspection to be conducted after sterilization and before shipping of the laser handpieces.