PD-L1 IHC 22C3 pharmDX

FDA Premarket Approval P150013 S020

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

The center for devices and radiological health (cdrh) of the food and drug administration (fda) has completed its review of your premarket approval application (pma) supplement for the pd-l1 ihc 22c3 pharmdx for expanding the indications to include detection of pd-l1 protein in patients with triple-negative breast cancer (tnbc) for treatment with keytruda. We are pleased to inform you that the pma supplement is approved. You may begin commercial distribution of the device in accordance with the conditions of approval described.

DevicePD-L1 IHC 22C3 pharmDX
Generic NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
ApplicantDAKO NORTH AMERICA, INC.
Date Received2020-06-29
Decision Date2020-11-13
PMAP150013
SupplementS020
Product CodePLS 
Advisory CommitteePathology
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address DAKO NORTH AMERICA, INC. 6392 Via Real carpinteria, CA 93013

Supplemental Filings

Supplement NumberDateSupplement Type
P150013Original Filing
S020 2020-06-29 Panel Track
S019 2020-02-06 Normal 180 Day Track No User Fee
S018 2019-09-05 Normal 180 Day Track No User Fee
S017 2019-06-14 Normal 180 Day Track
S016 2019-02-25 Panel Track
S015 2019-02-15 30-day Notice
S014
S013 2018-12-21 30-day Notice
S012
S011 2018-06-25 Panel Track
S010 2018-03-12 30-day Notice
S009 2018-01-29 Panel Track
S008 2017-12-26 30-day Notice
S007 2017-09-21 Normal 180 Day Track No User Fee
S006 2017-04-19 Panel Track
S005 2017-04-17 30-day Notice
S004 2016-12-27 Real-time Process
S003 2016-08-19 Real-time Process
S002 2016-06-28 Real-time Process
S001 2015-12-31 Panel Track

NIH GUDID Devices

Device IDPMASupp
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05700573003563 P150013 000
05700573003563 P150013 000
05700573003563 P150013 000
05700573003563 P150013 000
05700573003563 P150013 000
05700573003563 P150013 000
05700573003563 P150013 000
05700573003563 P150013 000
05700573003563 P150013 000
05700573003563 P150013 000
05700573003563 P150013 000
05700573003563 P150013 000
05700571107300 P150013 000
05700571107300 P150013 000
05700571107300 P150013 000
05700571107300 P150013 000
05700571107300 P150013 000
05700571107300 P150013 000
05700571107300 P150013 000
05700571107300 P150013 000
05700571107300 P150013 000
05700571107300 P150013 000
05700571107300 P150013 000
05700571107300 P150013 000
05700571107300 P150013 000
05700571107300 P150013 000
05700573003563 P150013 000

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