THINPREP IMAGING SYSTEM
FDA premarket approval P020002/S002 · decided 2006-04-28
Approval details
- PMA number
- P020002
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THINPREP IMAGING SYSTEM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Hologic, Inc.
- Date received
- 2006-03-30
- Decision date
- 2006-04-28
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR SOFTWARE AND LABELING MODIFICATIONS OF THE THINPREP IMAGING SYSTEM FOR REMOTE REVIEWING CAPABILITY & LABELING CHANGE FOR THE THINPREP IMAGING SYSTEM TO INCORPORATE A NEW LIMITATION FOR SPECIMEN REPROCESSING.
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