BOND Oracel HER2 IHC System

System, Test, Her-2/neu, Ihc

FDA Premarket Approval P090015 S008

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

Adding a second supplier for a reagent.

DeviceBOND Oracel HER2 IHC System
Classification NameSystem, Test, Her-2/neu, Ihc
Generic NameSystem, Test, Her-2/neu, Ihc
ApplicantLeica Biosystems
Date Received2019-07-24
Decision Date2019-09-12
PMAP090015
SupplementS008
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
S012 2020-08-28 30-day Notice
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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