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 | S008 |
Date Received | 10/27/2016 |
Decision Date | 01/30/2017 |
Product Code |
PJG |
Advisory Committee |
Pathology |
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 inclusion of the BRACAnalysis CDx - DNA Quantification Technical Manual, the BRACAnalysis CDx - Sanger Technical Manual, and the BRACAnalysis CDX – BART Technical Manual in place of several laboratory Standard Operating Procedures. |
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