Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM |
Generic Name | SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION |
Applicant | CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. KENNESAW, GA 30144 |
PMA Number | P970029 |
Supplement Number | S024 |
Date Received | 01/29/2013 |
Decision Date | 05/31/2013 |
Product Code |
MNO |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR DESIGN CHANGES TO THE DISTAL FIBERS OF THE THREE HAND-PIECE MODELS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TMR2000 HOLMIUM LASER SYSTEM AND IS INDICATED FOR TRANS-MYOCARDIAL REVASCULARIZATION IN PATIENTS WITH ANGINA REFRACTORY TO MEDICAL TREATMENT AND SECONDARY TO OBJECTIVELY DEMONSTRATED CORONARY ARTERY ATHEROSCLEROSIS AND WITH A REGION OF THE MYOCARDIUM WITH REVERSIBLE ISCHEMIA NOT AMENABLE TO DIRECT CORONARY REVASCULARIZATION. |
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