ThinPrep Processors and ThinPrep Imaging System
FDA premarket approval P950039/S039 · decided 2020-08-12
Approval details
- PMA number
- P950039
- Supplement
- S039
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ThinPrep Processors and ThinPrep Imaging System
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 2020-04-15
- Decision date
- 2020-08-12
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- Approval of an alternate supplier for the membrane material for the ThinPrep Pap Test Filter used in the ThinPrep processors.
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