THINPREP IMAGING SYSTEM LABELING
FDA premarket approval P020002/S005 · decided 2010-09-16
Approval details
- PMA number
- P020002
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THINPREP IMAGING SYSTEM LABELING
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Hologic, Inc.
- Date received
- 2010-08-19
- Decision date
- 2010-09-16
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR LABELING REVISIONS REGARDING WORKLOAD CALCULATION.
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