THINPREP 2000 SYSTEM
FDA premarket approval P950039/S016 · decided 2006-01-18
Approval details
- PMA number
- P950039
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THINPREP 2000 SYSTEM
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 2005-07-22
- Decision date
- 2006-01-18
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR ADDITIONAL CLAIMS TO THE CURRENT LABELING. THE ADDITIONAL CLAIMS CONSIST OF EXTENSION OF THE EXPIRATION DATE OF THE PRESERVCYT SAMPLE VIALS TO SIX WEEKS, REPROCESSING "UNSATISFACTORY FOR EVALUATION" SLIDES WITH A CYTOLYT SOLUTION AND GLACIAL ACETIC ACID WASH, AND REFERENCE TO THE GEN-PROBE APTIMA ASSAYS FOR THE DETECTION OF CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE.
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