Path Vysion HER-2 DNA Probe Kit

System, Test, Her-2/neu, Nucleic Acid Or Serum

FDA Premarket Approval P980024 S017

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

Changes to the manufacturing process and manufacturing site of a suppliers product.

DevicePath Vysion HER-2 DNA Probe Kit
Classification NameSystem, Test, Her-2/neu, Nucleic Acid Or Serum
Generic NameSystem, Test, Her-2/neu, Nucleic Acid Or Serum
ApplicantABBOTT MOLECULAR, INC.
Date Received2018-02-16
Decision Date2018-03-12
PMAP980024
SupplementS017
Product CodeMVD
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT MOLECULAR, INC. 1300 East Touhy Avenue des Plaines, IL 60018

Supplemental Filings

Supplement NumberDateSupplement Type
P980024Original Filing
S022 2022-02-18 30-day Notice
S021 2020-11-16 30-day Notice
S020 2019-04-10 30-day Notice
S019 2018-08-10 30-day Notice
S018 2018-06-15 30-day Notice
S017 2018-02-16 30-day Notice
S016 2017-11-08 30-day Notice
S015 2016-09-02 30-day Notice
S014 2016-06-01 30-day Notice
S013 2014-06-16 30-day Notice
S012 2013-11-25 30-day Notice
S011 2013-11-05 30-day Notice
S010 2013-01-16 30-day Notice
S009 2012-11-15 30-day Notice
S008 2012-06-21 Special (immediate Track)
S007 2012-06-14 135 Review Track For 30-day Notice
S006 2011-10-17 135 Review Track For 30-day Notice
S005 2011-02-22 135 Review Track For 30-day Notice
S004 2010-12-22 30-day Notice
S003 2009-01-15 30-day Notice
S002 2005-06-20 Normal 180 Day Track No User Fee
S001 2001-03-30 Panel Track

NIH GUDID Devices

Device IDPMASupp
00884999001763 P980024 001
00884999001756 P980024 001
00884999001732 P980024 001

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