AUTOPAP PRIMARY SCREENING SYSTEM
FDA premarket approval P950009/S004 · decided 2001-10-05
Approval details
- PMA number
- P950009
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AUTOPAP PRIMARY SCREENING SYSTEM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Bd Diagnostics
- Date received
- 1999-10-01
- Decision date
- 2001-10-05
- Days to decision
- 735 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR USE OF THE DEVICE WITH AUTOCYTE PREP CERVICAL CYTOLOGY SLIDES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AUTOPAP PRIMARY SCREENING SYSTEM AND IS INDICATED FOR: THE AUTOPAP PRIMARY SCREENING SYSTEM IS AN AUTOMATED CERVICAL CYTOLOGY SCREENING DEVICE INTENDED FOR USE IN INITIAL SCREENING OF CERVICAL CYTOLOGY SLIDES. THE AUTOPAP PRIMARY SCREENING SYSTEM IDENTIFIES UP TO 25% OF SUCCESSFULLY PROCESSED SLIDES AS REQUIRING NO FURTHER REVIEW. THE AUTOPAP PRIMARY SCREENIN
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