PMA P020002S002
- Device
- THINPREP IMAGING SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P020002
- Supplement
- S002
- Product code
- MNM
- Decision date
- 2006-04-28
- Classification
- Reader, Cervical Cytology Slide, Automated
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order statement
- APPROVAL FOR SOFTWARE AND LABELING MODIFICATIONS OF THE THINPREP IMAGING SYSTEM FOR REMOTE REVIEWING CAPABILITY & LABELING CHANGE FOR THE THINPREP IMAGING SYSTEM TO INCORPORATE A NEW LIMITATION FOR SPECIMEN REPROCESSING.
Current openFDA PMA Record#
- Device
- THINPREP IMAGING SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P020002
- Supplement
- S002
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2006-04-28
- Decision code
- APPR
- Date received
- 2006-03-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE AND LABELING MODIFICATIONS OF THE THINPREP IMAGING SYSTEM FOR REMOTE REVIEWING CAPABILITY & LABELING CHANGE FOR THE THINPREP IMAGING SYSTEM TO INCORPORATE A NEW LIMITATION FOR SPECIMEN REPROCESSING.