THINPREP IMAGING SYSTEM
FDA premarket approval P020002/S001 · decided 2005-06-08
Approval details
- PMA number
- P020002
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- THINPREP IMAGING SYSTEM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Hologic, Inc.
- Date received
- 2005-05-03
- Decision date
- 2005-06-08
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT CYTYC CORPORATION, MARLBOROUGH, MASSACHUSETTS.
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