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Device | CARDIOGENESIS TMR 2000 HOLMIUM LASER SYSTEM |
Generic Name | SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION |
Applicant | CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. KENNESAW, GA 30144 |
PMA Number | P970029 |
Supplement Number | S017 |
Date Received | 03/19/2010 |
Decision Date | 04/15/2010 |
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 MODIFICATION OF AN EXISTING WARNING STATEMENT TO STATE: ¿EACH HANDPIECE DELIVERY SYTEM IS SUPPLIED STERILE FOR SINGLE USE ONLY. DO NOT REUSE OR RESTERILIZE. ANY ATTEMPT TO CLEAN AND RESTERILIZE CAN DAMAGE THE FIBEROPTIC.¿ |
Post-Approval Study | Show Report Schedule and Study Progress |