ThinPrep Processor and ThinPrep Imaging System
FDA premarket approval P950039/S037 · decided 2018-12-20
Approval details
- PMA number
- P950039
- Supplement
- S037
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ThinPrep Processor and ThinPrep Imaging System
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 2018-11-23
- Decision date
- 2018-12-20
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- Discontinuation of a lot qualification step for a raw material.
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