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 | FoundationOne CDx |
Generic Name | next generation sequencing oncology panel, somatic or germline variant detection system |
Applicant |
Foundation Medicine, Inc. |
150 second street, 1st floor |
cambridge, MA 02141 |
|
PMA Number | P170019 |
Supplement Number | S006 |
Date Received | 12/26/2018 |
Decision Date | 12/03/2019 |
Product Code |
PQP
|
Docket Number | 19M-5741 |
Notice Date | 12/06/2019 |
Advisory Committee |
Pathology |
Supplement Type | panel track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
Approval order for extending the label claim to include an indication for PIQRAY (alpelisib) in breast cancer patients with PIK3CA C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y alterations. |
Approval Order |
Approval Order
|
Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
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