PMA P950039S037
- Device
- ThinPrep Processor and ThinPrep Imaging System
- Applicant
- Hologic, Inc.
- PMA number
- P950039
- Supplement
- S037
- Product code
- MKQ
- Decision date
- 2018-12-20
- Classification
- Processor, Cervical Cytology Slide, Automated
- Generic name
- Processor, cervical cytology slide, automated
- Approval order statement
- Discontinuation of a lot qualification step for a raw material.
Current openFDA PMA Record#
- Device
- ThinPrep Processor and ThinPrep Imaging System
- Applicant
- Hologic, Inc.
- PMA number
- P950039
- Supplement
- S037
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 2018-12-20
- Decision code
- OK30
- Date received
- 2018-11-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Discontinuation of a lot qualification step for a raw material.