Epi proColon

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Premarket Approval P130001 S005

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

A change of storage and distribution facility

• Device: Epi proColon
• Classification Name: System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
• Generic Name: System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
• Applicant: EPIGENOMICS AG
• Date Received: 2019-08-06
• Decision Date: 2019-08-30
• PMA: P130001
• Supplement: S005
• Product Code: PHP
• Advisory Committee: Pathology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: EPIGENOMICS AG geneststr.5 berlin

Supplemental Filings

Supplement Number	Date	Supplement Type
P130001		Original Filing
S007	2021-06-21	Real-time Process
S006
S005	2019-08-06	30-day Notice
S004	2018-02-20	30-day Notice
S003
S002	2016-05-10	Normal 180 Day Track No User Fee
S001	2016-04-29	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
04260400670036	P130001	000
04260400670029	P130001	000
04260400670012	P130001	000