PMA P020002S007
- Device
- THINPREP IMAGING SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P020002
- Supplement
- S007
- Product code
- MNM
- Decision date
- 2014-04-29
- Classification
- Reader, Cervical Cytology Slide, Automated
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order statement
- APPROVAL FOR THE INTRODUCTION OF THE THINPREP® IMAGER DUO IMAGING STATION, HARDWARE (CAMERA AND EXTERIOR HOUSING) CHANGES, AND ASSOCIATED SOFTWARE CHANGES.
Current openFDA PMA Record#
- Device
- THINPREP IMAGING SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P020002
- Supplement
- S007
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2014-04-29
- Decision code
- APPR
- Date received
- 2014-01-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE INTRODUCTION OF THE THINPREP® IMAGER DUO IMAGING STATION, HARDWARE (CAMERA AND EXTERIOR HOUSING) CHANGES, AND ASSOCIATED SOFTWARE CHANGES.