THINPREP IMAGING SYSTEM

Reader, Cervical Cytology Slide, Automated

FDA Premarket Approval P020002 S010

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 use of the thinprep imaging system with the slides prepared by the thinprep 5000 slide processor.

DeviceTHINPREP IMAGING SYSTEM
Classification NameReader, Cervical Cytology Slide, Automated
Generic NameReader, Cervical Cytology Slide, Automated
ApplicantHOLOGIC, INC.
Date Received2014-11-14
Decision Date2015-06-02
PMAP020002
SupplementS010
Product CodeMNM
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address HOLOGIC, INC. 250 Campus Drive marlborough, MA 01752

Supplemental Filings

Supplement NumberDateSupplement Type
P020002Original Filing
S010 2014-11-14 Normal 180 Day Track
S009 2014-10-16 Real-time Process
S008 2014-06-20 Real-time Process
S007 2014-01-30 Real-time Process
S006 2011-11-29 Real-time Process
S005 2010-08-19 Special (immediate Track)
S004
S003 2007-07-11 Normal 180 Day Track No User Fee
S002 2006-03-30 Real-time Process
S001 2005-05-03 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
15420045508163 P020002 000
15420045507265 P020002 000
15420045507258 P020002 000
15420045504103 P020002 000
15420045504097 P020002 000
15420045504080 P020002 000
15420045504042 P020002 000
15420045504035 P020002 000
15420045501041 P020002 000
15420045501034 P020002 000
15420045500990 P020002 000
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15420045500914 P020002 007
15420045507258 P020002 010
15420045507265 P020002 010

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