THINPREP(R) PROCESSOR
FDA premarket approval P950039/S003 · decided 1997-04-08
Approval details
- PMA number
- P950039
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THINPREP(R) PROCESSOR
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 1996-09-27
- Decision date
- 1997-04-08
- Days to decision
- 193 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR THE USE OF POLYETHYLENE TEREPHTHALATE (POLYESTER) AS AN ALTERNATIVE MEMBRANE MATERIAL FOR THE TRANSCYT FILTER FOR GYNECOLOGICAL SPECIMENS AND THEU SE OF THE POLYCARBONATE TRANSCYT FILTERS WITH THE MODIFIED SOFTWARE ON THE THINPREP 2000 SYSTEM
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510(k) clearances by this applicant
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