FoundationOne CDx

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Premarket Approval P170019 S004

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.

Pre-market Approval Supplement Details

Approval order for extending the label claim to include an indication for lynparza (olaparib) in ovarian cancer patients with brca1/2 alterations.

DeviceFoundationOne CDx
Classification NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantFoundation Medicine, Inc.
Date Received2018-09-24
Decision Date2019-07-01
PMAP170019
SupplementS004
Product CodePQP
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Foundation Medicine, Inc. 150 Second Street, 1st Floor cambridge, MA 02141

Supplemental Filings

Supplement NumberDateSupplement Type
P170019Original Filing
S038 2022-08-29 Special (immediate Track)
S037
S036
S035 2022-06-09 Normal 180 Day Track No User Fee
S034 2022-03-18 Normal 180 Day Track No User Fee
S033 2021-12-23 Real-time Process
S032
S031
S030 2021-07-01 Normal 180 Day Track
S029
S028 2021-03-23 Normal 180 Day Track
S027
S026 2020-12-28 Normal 180 Day Track
S025
S024
S023 2020-12-01 Normal 180 Day Track
S022
S021 2020-10-29 Normal 180 Day Track
S020 2020-07-20 Real-time Process
S019 2020-04-27 Real-time Process
S018 2020-04-16 30-day Notice
S017
S016
S015 2019-12-16 Panel Track
S014
S013 2019-10-31 Panel Track
S012 2019-10-21 Special (immediate Track)
S011
S010
S009 2019-07-23 Special (immediate Track)
S008 2019-04-09 Normal 180 Day Track
S007
S006
S005 2018-10-12 Normal 180 Day Track
S004 2018-09-24 Normal 180 Day Track
S003 2018-08-30 Real-time Process
S002 2018-08-24 Real-time Process
S001

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