PMA P950039S036
- Device
- ThinPrep Integrated Imager
- Applicant
- Hologic, Inc.
- PMA number
- P950039
- Supplement
- S036
- Product code
- MNM
- Decision date
- 2018-04-18
- Classification
- Reader, Cervical Cytology Slide, Automated
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P950039S036B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- ThinPrep Integrated Imager
- Applicant
- Hologic, Inc.
- PMA number
- P950039
- Supplement
- S036
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2018-04-18
- Decision code
- APPR
- Date received
- 2017-07-31
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.