PMA P970029S035
- Device
- TMR Holmium Laser System
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S035
- Product code
- MNO
- Decision date
- 2017-07-28
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order statement
- Change to specify an upper specification limit (USL) of 4.0 lbs/in for packaging with a chevron or peel able area for aseptic presentation.
Current openFDA PMA Record#
- Device
- TMR Holmium Laser System
- Applicant
- Cryolife, Inc.
- PMA number
- P970029
- Supplement
- S035
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2017-07-28
- Decision code
- OK30
- Date received
- 2017-06-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to specify an upper specification limit (USL) of 4.0 lbs/in for packaging with a chevron or peel able area for aseptic presentation.