PMA P970029S039
- Device
- TMR Holmium Laser System
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S039
- Product code
- MNO
- Decision date
- 2019-05-02
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- Additional equipment to measure the seal strength of product pouches.
Current openFDA PMA Record#
- Device
- TMR Holmium Laser System
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S039
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2019-05-02
- Decision code
- OK30
- Date received
- 2019-04-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional equipment to measure the seal strength of product pouches.