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 | S021 |
Date Received | 08/16/2012 |
Decision Date | 09/13/2012 |
Product Code |
MNO |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO CLARIFY THE DEVICE DESCRIPTION, WARNINGS, ADVERSE EFFECTS AND DEVICE OPERATING INSTRUCTIONS. |
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