FDA.reportPublic FDA data

PMA P970029S026

Device
CARDIOGENESIS TMR SYSTEM
Applicant
Cryolife, Inc.
PMA number
P970029
Supplement
S026
Product code
MNO
Decision date
2014-05-07
Classification
System, Laser, Transmyocardial Revascularization
Generic name
SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
Approval order statement
APPROVAL FOR INCLUDING THE POST APPROVAL STUDY LABELING CHANGES OF THE PEARL 8.0 DEVICE INTO THE INSTRUCTIONS FOR USE OF THE PEARL 5.0 AND THE SOLOGRIP III HANDPIECES AS WELL AS ADDING SOME CLARIFYING STATEMENTS TO ENSURE THE SAFE HANDLING OF THE HANDPIECES.

Current openFDA PMA Record#

Device
CARDIOGENESIS TMR SYSTEM
Applicant
Cryolife, Inc.
PMA number
P970029
Supplement
S026
Product code
MNO
Generic name
SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
Decision date
2014-05-07
Decision code
APPR
Date received
2014-04-09
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR INCLUDING THE POST APPROVAL STUDY LABELING CHANGES OF THE PEARL 8.0 DEVICE INTO THE INSTRUCTIONS FOR USE OF THE PEARL 5.0 AND THE SOLOGRIP III HANDPIECES AS WELL AS ADDING SOME CLARIFYING STATEMENTS TO ENSURE THE SAFE HANDLING OF THE HANDPIECES.