BD FocalPoint GS Imaging System

FDA Premarket Approval P950009 S024

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 component replacement with the like-for-like objective lens

DeviceBD FocalPoint GS Imaging System
Generic NameReader, Cervical Cytology Slide, Automated
ApplicantBD DIAGNOSTICS
Date Received2021-03-04
Decision Date2021-03-29
PMAP950009
SupplementS024
Product CodeMNM 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BD DIAGNOSTICS 4025 Stirrup Creek Drive suite 400 durham, NC 27703

Supplemental Filings

Supplement NumberDateSupplement Type
P950009Original Filing
S024 2021-03-04 30-day Notice
S023 2019-11-19 30-day Notice
S022 2019-06-05 Normal 180 Day Track
S021 2016-05-19 30-day Notice
S020 2016-03-07 Normal 180 Day Track No User Fee
S019 2015-04-24 Real-time Process
S018 2014-11-12 Normal 180 Day Track
S017 2013-12-02 Real-time Process
S016 2012-07-05 Real-time Process
S015 2012-03-28 Normal 180 Day Track
S014 2012-01-17 Real-time Process
S013 2011-09-15 Real-time Process
S012 2010-08-17 Special (immediate Track)
S011 2009-12-10 30-day Notice
S010 2009-06-25 Normal 180 Day Track No User Fee
S009 2009-03-26 Real-time Process
S008 2007-10-02 Panel Track
S007
S006
S005 2001-10-26 Real-time Process
S004 1999-10-01 Normal 180 Day Track
S003 1998-10-13 Normal 180 Day Track
S002 1996-06-06 Panel Track
S001 1995-11-06 Special (immediate Track)

NIH GUDID Devices

Device IDPMASupp
00382904901899 P950009 008
00382904910877 P950009 015
00382904910860 P950009 015
00382904910853 P950009 015
00382904910907 P950009 015
00382904914646 P950009 022

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