BD FOCALPOINT SLIDE PROFILER

Reader, Cervical Cytology Slide, Automated

FDA Premarket Approval P950009 S015

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 the bd focalpoint slide profiler with the new digital primarycamera.

DeviceBD FOCALPOINT SLIDE PROFILER
Classification NameReader, Cervical Cytology Slide, Automated
Generic NameReader, Cervical Cytology Slide, Automated
ApplicantBD DIAGNOSTICS
Date Received2012-03-28
Decision Date2013-09-13
PMAP950009
SupplementS015
Product CodeMNM
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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
S026 2022-06-15 30-day Notice
S025 2021-09-02 Real-time Process
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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