Note: 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. |
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Device | THINPREP (R) IMAGING SYSTEM |
Generic Name | READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED |
Applicant | HOLOGIC, INC. 250 Campus Drive Marlborough, MA 01752 |
PMA Number | P020002 |
Date Received | 01/07/2002 |
Decision Date | 06/06/2003 |
APCB Date
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03/22/2017 |
Product Code |
MNM |
Docket Number | 03M-0339 |
Notice Date | 07/30/2003 |
Advisory Committee |
Pathology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S005 S006 S007 S008 S009 S010 |
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