Thinprep (R) Imaging System

FDA premarket approval P020002 · Reader, Cervical Cytology Slide, Automated

PMA numberP020002

Approval

Applicant
Hologic, Inc.
Received
January 7, 2002
Decision date
June 6, 2003 (APCB)
Supplements
9, latest June 2, 2015
Product code
MNM – Reader, Cervical Cytology Slide, Automated

Official FDA PMA record

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.