FOCALPOINT SYSTEMCREENING SYSTEM
FDA premarket approval P950009/S005 · decided 2001-11-02
Approval details
- PMA number
- P950009
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FOCALPOINT SYSTEMCREENING SYSTEM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Bd Diagnostics
- Date received
- 2001-10-26
- Decision date
- 2001-11-02
- Days to decision
- 7 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR NAME CHANGES FROM AUTPAP PRIMARY SCREENING SYSTEM AND AUTOPAP SYSTEM TO FOCALPOINT SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FOCALPOINT SYSTEM. THE FOCALPOINT SYSTEM (AUTOPAP PRIMARY SCREENING SYSTEM) IS INDICATED FOR: THE FOCALPOINT SYSTEM IS AN AUTOMATED CERVICEL CYTOLOGY SCREENING DEVICE INTENDED FOR USE IN INITIAL SCREENING OF CERVICAL CYTOLOGY CLIDES. THE FOCALPOINT SYSTEM IDENTIFIES UP TO 25% OF SUCCESSFULLY PROCESSED SLIDES AS REQUIRING NO FURTHER
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