THINPREP PROCESSOR 2000/3000 SYSTEM
FDA premarket approval P950039/S024 · decided 2012-04-09
Approval details
- PMA number
- P950039
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THINPREP PROCESSOR 2000/3000 SYSTEM
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 2012-02-14
- Decision date
- 2012-04-09
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR AN EXTENSION OF THE SHELF LIFE FOR THINPREP PAP TEST FILTERS.
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