BOND Oracle HER2 IHC System

FDA Premarket Approval P090015 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

Addition of a new supplier of reagent

DeviceBOND Oracle HER2 IHC System
Generic NameSystem, Test, Her-2/neu, Ihc
ApplicantLeica Biosystems
Date Received2020-04-02
Decision Date2020-04-24
Product CodeMVC 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Leica Biosystems 36 Cherry Hill Drive danvers, MA 01923

Supplemental Filings

Supplement NumberDateSupplement Type
P090015Original Filing
S011 2020-04-02 30-day Notice
S010 2019-12-13 30-day Notice
S009 2019-09-09 30-day Notice
S008 2019-07-24 30-day Notice
S007 2019-04-01 30-day Notice
S006 2018-10-26 Real-time Process
S005 2017-06-27 30-day Notice
S004 2017-02-02 30-day Notice
S003 2015-04-20 Special (immediate Track)
S002 2014-11-28 Real-time Process
S001 2013-07-26 Normal 180 Day Track

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