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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 | S020 |
Date Received | 06/27/2012 |
Decision Date | 07/26/2012 |
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 TO ADD A WARNING TO THE OUTER BOX OF THE SOLOGRIP III HANDPIECE. |