| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | BD PREPSTAIN SYSTEM |
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| Generic Name | Processor, cervical cytology slide, automated |
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| Applicant | BD Diagnostic Systems
4025 STIRRUP CREEK DRIVE
SUITE 400
DURHAM, NC 27703 |
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| PMA Number | P970018 |
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| Date Received | 05/12/1997 |
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| Decision Date | 06/17/1999 |
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| Product Code |
MKQ |
| Docket Number | 99M-2144 |
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| Notice Date | 07/07/1999 |
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| Advisory Committee |
Pathology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
This device is indicated as a liquid-based, thin-layer cell preparation process. The system produces slides that are intended as replacements for conventional gynecologic Pap smears. AutoCyte PREP slides are intended for use in the screening and detection of cervical cancer, precancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S009 S010 S012 S014
S015 S016 S017 S018 S019 S020 S021 S023 S024 S025 S027 S028
S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040
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