PMA P020002S005
- Device
- THINPREP IMAGING SYSTEM LABELING
- Applicant
- Hologic, Inc.
- PMA number
- P020002
- Supplement
- S005
- Product code
- MNM
- Decision date
- 2010-09-16
- Classification
- Reader, Cervical Cytology Slide, Automated
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order statement
- APPROVAL FOR LABELING REVISIONS REGARDING WORKLOAD CALCULATION.
Current openFDA PMA Record#
- Device
- THINPREP IMAGING SYSTEM LABELING
- Applicant
- Hologic, Inc.
- PMA number
- P020002
- Supplement
- S005
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2010-09-16
- Decision code
- APPR
- Date received
- 2010-08-19
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING REVISIONS REGARDING WORKLOAD CALCULATION.