THINPREP (R) IMAGING SYSTEM
FDA premarket approval P020002 · decided 2003-06-06
Approval details
- PMA number
- P020002
- Trade name
- THINPREP (R) IMAGING SYSTEM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Hologic, Inc.
- Date received
- 2002-01-07
- Decision date
- 2003-06-06
- Days to decision
- 515 days
- Decision code
- APCB
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR THE THINPREP IMAGING SYSTEM. THE DEVICE IS INDICATED FOR ASSISTING IN PRIMARY CERVICAL CANCER SCREENING OF THINPREP PAP TEST SLIDES FOR THE PRESENCE OF ATYPICAL CELLS, CERVICAL NEOPLASIA, INCLUDING ITS PRECURSOR LESIONS (LOW GRADE SQUAMOUS INTRAEPITHELIAL LESIONS, HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESIONS, AND CARCINOMA AS WELL AS ALL OTHER CYTOLOGICAL CRITERIA AS DEFINED BY THE 2001 BETHESDA SYSTEM: TERMINOLOGY FOR REPORTING RESULTS OF CERVICAL CYTOLOGY.
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