PMA P020002S009
- Device
- THINPREP IMAGING SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P020002
- Supplement
- S009
- Product code
- MNM
- Decision date
- 2015-01-12
- Classification
- Reader, Cervical Cytology Slide, Automated
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE REVIEW SCOPE MANUAL PLUS MICROSCOPE FRAME OF THE THINPREP IMAGING SYSTEM.
Current openFDA PMA Record#
- Device
- THINPREP IMAGING SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P020002
- Supplement
- S009
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2015-01-12
- Decision code
- APPR
- Date received
- 2014-10-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE REVIEW SCOPE MANUAL PLUS MICROSCOPE FRAME OF THE THINPREP IMAGING SYSTEM.