AUTOPAP SYSTEM

Reader, Cervical Cytology Slide, Automated

FDA Premarket Approval P950009 S003

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for removal of the stage three-alarm unit. The device is to be used only on conventionally prepared pap smear slides and is intended to detect slides with evidence of squamous carcinoma and adenocarcinoma and their usual precursor conditions; it is not intended to be used on slides designated by the laboratory as "high risk. " intended users are trained cytology laboratory personnel operating under the direct supervision of a qualified cytology supervisor or laboratory manager/director.

• Device: AUTOPAP SYSTEM
• Classification Name: Reader, Cervical Cytology Slide, Automated
• Generic Name: Reader, Cervical Cytology Slide, Automated
• Applicant: BD DIAGNOSTICS
• Date Received: 1998-10-13
• Decision Date: 1999-01-19
• PMA: P950009
• Supplement: S003
• Product Code: MNM
• Advisory Committee: Pathology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: BD DIAGNOSTICS 4025 Stirrup Creek Drive suite 400 durham, NC 27703

Supplemental Filings

Supplement Number	Date	Supplement Type
P950009		Original Filing
S026	2022-06-15	30-day Notice
S025	2021-09-02	Real-time Process
S024	2021-03-04	30-day Notice
S023	2019-11-19	30-day Notice
S022	2019-06-05	Normal 180 Day Track
S021	2016-05-19	30-day Notice
S020	2016-03-07	Normal 180 Day Track No User Fee
S019	2015-04-24	Real-time Process
S018	2014-11-12	Normal 180 Day Track
S017	2013-12-02	Real-time Process
S016	2012-07-05	Real-time Process
S015	2012-03-28	Normal 180 Day Track
S014	2012-01-17	Real-time Process
S013	2011-09-15	Real-time Process
S012	2010-08-17	Special (immediate Track)
S011	2009-12-10	30-day Notice
S010	2009-06-25	Normal 180 Day Track No User Fee
S009	2009-03-26	Real-time Process
S008	2007-10-02	Panel Track
S007
S006
S005	2001-10-26	Real-time Process
S004	1999-10-01	Normal 180 Day Track
S003	1998-10-13	Normal 180 Day Track
S002	1996-06-06	Panel Track
S001	1995-11-06	Special (immediate Track)

NIH GUDID Devices

Device ID	PMA	Supp
00382904901899	P950009	008
00382904910877	P950009	015
00382904910860	P950009	015
00382904910853	P950009	015
00382904910907	P950009	015
00382904914646	P950009	022