THINPREP 2000 SYSTEM
FDA premarket approval P950039/S015 · decided 2005-09-28
Approval details
- PMA number
- P950039
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Trade name
- THINPREP 2000 SYSTEM
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 2005-04-01
- Decision date
- 2005-09-28
- 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 APPROVED LABELING FOR THINPREP 2000 SYSTEM REGARDING REMOVAL OF A 4 ML ALIQUOT FROM THE PRESERVCYT VIAL PRIOR TO PREPARATION OF THE THINPREP PAP TEST(TPPT). THIS ALIQUOT IS ONLY TO BE USED TO SUPPORT PERFORMANCE OF ANCILLARY TESTS APPROVED BY THE FDA ON PRESERVCYT MATERIAL.
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