ThinPrep Genesis Processor

FDA Premarket Approval P950039 S040

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 hologic thinprep genesis processor.

DeviceThinPrep Genesis Processor
Generic NameProcessor, Cervical Cytology Slide, Automated
ApplicantHOLOGIC, INC.
Date Received2020-09-30
Decision Date2021-05-14
PMAP950039
SupplementS040
Product CodeMKQ 
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address HOLOGIC, INC. 250 Campus Drive marlborough, MA 01752

Supplemental Filings

Supplement NumberDateSupplement Type
P950039Original Filing
S040 2020-09-30 Normal 180 Day Track
S039 2020-04-15 135 Review Track For 30-day Notice
S038 2019-06-05 Real-time Process
S037 2018-11-23 30-day Notice
S036 2017-07-31 Panel Track
S035 2016-10-05 Special (immediate Track)
S034 2015-10-01 Real-time Process
S033
S032 2014-11-21 30-day Notice
S031 2014-09-30 Real-time Process
S030 2014-08-29 Special (immediate Track)
S029 2014-08-15 30-day Notice
S028 2014-04-02 30-day Notice
S027 2013-12-31 30-day Notice
S026 2013-06-27 Normal 180 Day Track
S025
S024 2012-02-14 Real-time Process
S023
S022
S021 2010-02-25 30-day Notice
S020 2009-10-01 30-day Notice
S019
S018 2007-06-11 Normal 180 Day Track No User Fee
S017 2006-09-05 Special (immediate Track)
S016 2005-07-22 Normal 180 Day Track
S015 2005-04-01 Normal 180 Day Track
S014 2005-02-14 Normal 180 Day Track No User Fee
S013 2004-10-18 Normal 180 Day Track No User Fee
S012 2004-08-10 Normal 180 Day Track
S011 2003-10-31 Normal 180 Day Track No User Fee
S010 2003-02-19 Special (immediate Track)
S009 2003-01-21 Special (immediate Track)
S008 2001-12-10 Normal 180 Day Track
S007 2001-02-23 Normal 180 Day Track
S006 1999-10-27 Normal 180 Day Track
S005 1996-10-15
S004 1996-10-02 Normal 180 Day Track
S003 1996-09-27 Normal 180 Day Track
S002 1996-07-30 Normal 180 Day Track
S001 1996-06-07 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
15420045513945 P950039 000
15420045513952 P950039 000
15420045501072 P950039 000
15420045508040 P950039 000
25420045501093 P950039 000
25420045501109 P950039 000
15420045500839 P950039 028
15420045500846 P950039 028
15420045501072 P950039 028
15420045504004 P950039 028
15420045504011 P950039 028
25420045501086 P950039 028
25420045501093 P950039 028
25420045501109 P950039 028
15420045504158 P950039 032
15420045507005 P950039 032

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