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 | S001 |
Date Received | 06/19/2015 |
Decision Date | 04/29/2016 |
Product Code |
PJG |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to add additional critical instruments of the same type using approved protocols. |
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