FDA.reportPublic FDA data

PMA P970029S038

Device
TMR Holmium Laser System
Applicant
Cryolife, Inc.
Product code
MNO
Decision date
2021-01-21
Generic name
SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
Approval order statement
Approval for a manufacturing site located at Parker Hannifin (CSS Merrillville), 1201 East 86th Place, Merrillville, Indiana 46410, for manufacturing of the SoloGrip III Handpiece which is part of the Cardiogenesis Laser System.

Current openFDA PMA Record#

Device
TMR Holmium Laser System
Applicant
Cryolife, Inc.
PMA number
P970029
Supplement
S038
Product code
MNO
Generic name
SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
Decision date
2021-01-21
Decision code
APPR
Date received
2018-11-02
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site located at Parker Hannifin (CSS Merrillville), 1201 East 86th Place, Merrillville, Indiana 46410, for manufacturing of the SoloGrip III Handpiece which is part of the Cardiogenesis Laser System.