HER2 FISH PHARMADX KIT

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

FDA Premarket Approval P040005 S009

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

Approval for addition of kadcyla (ado-trastuzumab emtansine) in the labeling of her2 iq-fish pharmdx kit.

DeviceHER2 FISH PHARMADX KIT
Classification NameSystem, Test, Her-2/neu, Nucleic Acid Or Serum
Generic NameSystem, Test, Her-2/neu, Nucleic Acid Or Serum
ApplicantDAKO DENMARK A/S
Date Received2012-08-24
Decision Date2013-02-22
PMAP040005
SupplementS009
Product CodeMVD
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address DAKO DENMARK A/S 42 Produktionsvej 2600 Glostrup DK-26-2600

Supplemental Filings

Supplement NumberDateSupplement Type
P040005Original Filing
S014 2017-03-13 30-day Notice
S013 2016-03-16 30-day Notice
S012 2016-01-08 30-day Notice
S011 2015-08-13 30-day Notice
S010 2013-08-01 30-day Notice
S009 2012-08-24 Normal 180 Day Track
S008 2012-07-11 30-day Notice
S007 2011-12-14 Normal 180 Day Track
S006 2011-12-05 Normal 180 Day Track
S005 2010-04-20 Panel Track
S004 2010-03-10 135 Review Track For 30-day Notice
S003 2008-07-10 Real-time Process
S002 2007-10-29 Real-time Process
S001 2005-08-15 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
05700572032465 P040005 001

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