- Device
- ThinPrep Processors and ThinPrep Imaging System
- Applicant
- Hologic, Inc.
- PMA number
- P950039
- Supplement
- S039
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 2020-08-12
- Decision code
- APPR
- Date received
- 2020-04-15
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval of an alternate supplier for the membrane material for the ThinPrep Pap Test Filter used in the ThinPrep processors.