ThinPrep Integrated Imager
FDA premarket approval P950039/S036 · decided 2018-04-18
Approval details
- PMA number
- P950039
- Supplement
- S036
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ThinPrep Integrated Imager
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Hologic, Inc.
- Date received
- 2017-07-31
- Decision date
- 2018-04-18
- Days to decision
- 261 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- Approval of the Hologic ThinPrep® Integrated Imager. The device uses computer imaging technology to assist 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 cytologic criteria as defined by the Bethesda System: Terminology for Reporting Results of Cervical Cytology.
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