PMA P230009S006

Device: Shield
Applicant: Guardant Health, Inc.
PMA number: P230009
Supplement: S006
Product code: PHP
Decision date: 2025-04-28
Classification: Medical Genetics
Generic name: System, colorectal neoplasia, DNA methylation and hemoglobin detection
Approval order statement: approval of a secondary supplier of critical raw materials, scale-up of the manufacturing process for a device component, and expansion of QC testing facilities at an existing site

Current openFDA PMA Record#

Device: Shield
Applicant: Guardant Health, Inc.
PMA number: P230009
Supplement: S006
Product code: PHP
Generic name: System, colorectal neoplasia, DNA methylation and hemoglobin detection
Decision date: 2025-04-28
Decision code: OK30
Date received: 2025-04-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval of a secondary supplier of critical raw materials, scale-up of the manufacturing process for a device component, and expansion of QC testing facilities at an existing site