PMA P970029S037
- Device
- TMR Holmium Laser System
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S037
- Product code
- MNO
- Decision date
- 2018-07-10
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- New seal strength specification for the CardioGenesis handpiece pouch.
Current openFDA PMA Record#
- Device
- TMR Holmium Laser System
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S037
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2018-07-10
- Decision code
- OK30
- Date received
- 2018-06-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New seal strength specification for the CardioGenesis handpiece pouch.