Guardant360® CDx

FDA Premarket Approval P200010 S011

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

DeviceGuardant360® CDx
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantGuardant Health, Inc.505 Penobscot Driveredwood City, CA 94063 PMA NumberP200010 Supplement NumberS011 Date Received07/01/2022 Decision Date07/29/2022 Product Code PQP  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-07-01
Decision Date2022-07-29
PMAP200010
SupplementS011
Product CodePQP 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressGuardant Health, Inc.
505 Penobscot Drive
redwood City, CA 94063 PMA NumberP200010 Supplement NumberS011 Date Received07/01/2022 Decision Date07/29/2022 Product Code PQP  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Relocation Of The Manufacturing Room For Reagent Components.

Supplemental Filings

Supplement NumberDateSupplement Type
P200010Original Filing
S011 2022-07-01 30-day Notice
S010
S009
S008
S007 2022-02-02 30-day Notice
S006
S005 2021-12-17 Real-time Process
S004
S003
S002 2020-12-18 Panel Track
S001 2020-11-20 Panel Track

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