THINPREP (R) IMAGING SYSTEM

Reader, Cervical Cytology Slide, Automated

FDA Premarket Approval P020002

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the thinprep imaging system. The device is indicated for assisting in primary cervical cancer screening of thinprep pap test slides for the presence of atypical cells, cervical neoplasia, including its precursor lesions (low grade squamous intraepithelial lesions, high grade squamous intraepithelial lesions, and carcinoma as well as all other cytological criteria as defined by the 2001 bethesda system: terminology for reporting results of cervical cytology.

DeviceTHINPREP (R) IMAGING SYSTEM
Classification NameReader, Cervical Cytology Slide, Automated
Generic NameReader, Cervical Cytology Slide, Automated
ApplicantHOLOGIC, INC.
Date Received2002-01-07
Decision Date2003-06-06
Notice Date2003-07-30
PMAP020002
SupplementS
Product CodeMNM
Docket Number03M-0339
Advisory CommitteePathology
Expedited ReviewNo
Combination Product No
Applicant Address HOLOGIC, INC. 250 Campus Drive marlborough, MA 01752
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

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
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15420045507265 P020002 010

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