THINPREP PROCESSOR (MODEL TP-2000)
FDA premarket approval P950039/S008 · decided 2002-06-05
Approval details
- PMA number
- P950039
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THINPREP PROCESSOR (MODEL TP-2000)
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 2001-12-10
- Decision date
- 2002-06-05
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR THE PRESERVCYT SOLUTION COMPONENT OF THE THINPREP 2000 SYSTEM TO BE USED AS AN ALTERNATIVE COLLECTION AND TRANSPORT MEDIUM FOR GYNECOLOGIC SPECIMENS TESTED WITH THE ROCHE COBAS AMPLICOR CT/NG TEST.
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