MONOPREP PAP TEST
FDA premarket approval P040052/S006 · decided 2008-07-09
Approval details
- PMA number
- P040052
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MONOPREP PAP TEST
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 2008-01-18
- Decision date
- 2008-07-09
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR LABELING CHANGES BASED ON THE ANALYSIS OF DATA FROM THE POST-MARKET STUDY ENTITLED SURE (SPECIMEN UNSAT RATE EVALUATION). THESE CHANGES HAVE BEEN INCORPORATED INTO THE LABORATORY INFORMATION AND INSTRUCTIONS LABELING.
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