THINPREP PROCESSOR 2000/3000
FDA premarket approval P950039/S021 · decided 2010-03-18
Approval details
- PMA number
- P950039
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THINPREP PROCESSOR 2000/3000
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 2010-02-25
- Decision date
- 2010-03-18
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- ALTERNATE VENDOR FOR THE MEMBRANE MATERIAL FOR THE MANUFACTURE OF THE THINPREP GYN FILTER USED IN THE THINPREP PROCESSOR 2000 AND THINPREP PROCESSOR 3000.
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