PMA P020002
- Device
- THINPREP IMAGING SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P020002
- Supplement
- S010
- Product code
- MNM
- Decision date
- 2015-06-02
- Classification
- Reader, Cervical Cytology Slide, Automated
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order statement
- APPROVAL FOR USE OF THE THINPREP IMAGING SYSTEM WITH THE SLIDES PREPARED BY THE THINPREP 5000 SLIDE PROCESSOR.
Current openFDA PMA Record#
- Device
- THINPREP IMAGING SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P020002
- Supplement
- S010
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2015-06-02
- Decision code
- APPR
- Date received
- 2014-11-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR USE OF THE THINPREP IMAGING SYSTEM WITH THE SLIDES PREPARED BY THE THINPREP 5000 SLIDE PROCESSOR.