ThinPrep 5000 Processor
FDA premarket approval P950039/S038 · decided 2019-09-03
Approval details
- PMA number
- P950039
- Supplement
- S038
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ThinPrep 5000 Processor
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 2019-06-05
- Decision date
- 2019-09-03
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- Approval for software upgrade to the ThinPrep 5000 processor
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