PMA P970029S021

Device: CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM
Applicant: Cryolife, Inc.
PMA number: P970029
Supplement: S021
Product code: MNO
Decision date: 2012-09-13
Classification: System, Laser, Transmyocardial Revascularization
Generic name: SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
Approval order statement: APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO CLARIFY THE DEVICE DESCRIPTION, WARNINGS, ADVERSE EFFECTS AND DEVICE OPERATING INSTRUCTIONS.

Current openFDA PMA Record#

Device: CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM
Applicant: Cryolife, Inc.
PMA number: P970029
Supplement: S021
Product code: MNO
Generic name: SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
Decision date: 2012-09-13
Decision code: APPR
Date received: 2012-08-16
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO CLARIFY THE DEVICE DESCRIPTION, WARNINGS, ADVERSE EFFECTS AND DEVICE OPERATING INSTRUCTIONS.