PMA P020002S008
- Device
- THINPREP IMAGING SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P020002
- Supplement
- S008
- Product code
- MNM
- Decision date
- 2014-09-18
- Classification
- Reader, Cervical Cytology Slide, Automated
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order statement
- APPROVAL FOR MODIFICATIONS OF THE THINPREP IMAGER DUO IMAGING STATION SOFTWARE.
Current openFDA PMA Record#
- Device
- THINPREP IMAGING SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P020002
- Supplement
- S008
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2014-09-18
- Decision code
- APPR
- Date received
- 2014-06-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS OF THE THINPREP IMAGER DUO IMAGING STATION SOFTWARE.