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 | BRACAnalysis CDx |
Generic Name | Cancer-related germline gene mutation detection system |
Applicant | MYRIAD GENETIC LABORATORIES 320 Wakara Way Salt Lake City, UT 84108 |
PMA Number | P140020 |
Supplement Number | S018 |
Date Received | 09/21/2018 |
Decision Date | 12/19/2018 |
Product Code |
PJG |
Advisory Committee |
Pathology |
Clinical Trials | NCT01844986
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Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the BRACAnalysis CDx®, for gBRCA mutated ovarian cancer patients maintenance monotherapy with Lynparza® (olaparib). |
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