NMP22 BladderCheck Test

FDA Premarket Approval P940035 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

DeviceNMP22 BladderCheck Test
Generic NameSystem, Test, Tumor Marker, For Detection Of Bladder Cancer
ApplicantAbbott Diagnostics Scarborough, Inc.10 Southgate Roadscarborough, ME 04074 PMA NumberP940035 Supplement NumberS017 Date Received02/08/2022 Decision Date07/12/2022 Product Code NAH  Advisory Committee Immunology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Date Received2022-02-08
Decision Date2022-07-12
PMAP940035
SupplementS017
Product CodeNAH 
Advisory CommitteeImmunology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbbott Diagnostics Scarborough, Inc.
10 Southgate Road
scarborough, ME 04074 PMA NumberP940035 Supplement NumberS017 Date Received02/08/2022 Decision Date07/12/2022 Product Code NAH  Advisory Committee Immunology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval To Manufacture Alere NMP22 BladderChek Test Under Abbott Diagnostics Scarborough, Inc.’s New Brand Name: NMP22 BladderChek Test

Supplemental Filings

Supplement NumberDateSupplement Type
P940035Original Filing
S017 2022-02-08 Normal 180 Day Track No User Fee
S016 2021-05-27 30-day Notice
S015 2018-04-18 30-day Notice
S014 2017-01-30 30-day Notice
S013 2016-08-16 30-day Notice
S012 2016-04-06 30-day Notice
S011 2015-07-01 30-day Notice
S010 2013-07-10 Special (immediate Track)
S009 2013-03-18 30-day Notice
S008 2010-11-22 Normal 180 Day Track No User Fee
S007 2011-07-27 Normal 180 Day Track No User Fee
S006 2011-05-11 Normal 180 Day Track No User Fee
S005 2008-05-16 Normal 180 Day Track No User Fee
S004 2008-03-27 Normal 180 Day Track No User Fee
S003 2002-09-16 Normal 180 Day Track
S002 1999-07-23 Panel Track
S001 1996-12-16 Normal 180 Day Track

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