THINPREP PROCESSOR,
FDA premarket approval P950039/S035 · decided 2016-10-26
Approval details
- PMA number
- P950039
- Supplement
- S035
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THINPREP PROCESSOR,
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 2016-10-05
- Decision date
- 2016-10-26
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- Approval of labeling changes for the ThinPrep® 3000 Processor.
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