Pathology · PMA · 1995
PAPNET Testing System
Neuromedical Systems, Inc.. Approved by FDA on 8 November 1995 under submission P940029, product code MNM (reader, cervical cytology slide, automated). What FDA's record says, in FDA's words.
Device record · P940029
- Device. PAPNET Testing SystemDEVICE
- Company. Neuromedical Systems, Inc.COMPANY
- Decision. 8 November 1995, PMA, apwdDECISION
- Panel. PathologyPANEL
- Product code. MNM, Reader, Cervical Cytology Slide, AutomatedCODE
- Source. FDA database entrySOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA approved it for
The Indications for Use statement could not be read from a public decision document for this submission on the retrieval date (the document is absent, scanned without text, or filed under another number). FDA's database entry is the place to read it.
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 158 reports filed against devices carrying product code MNM. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
9 April 2026 · Malfunction · BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED · BECTON DICKINSON & CO. (SPARKS) · report 1119779-2026-00623
IT WAS REPORTED WHILE USING BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED, THERE WAS 1 FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
9 April 2026 · Malfunction · BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED · BECTON DICKINSON & CO. (SPARKS) · report 1119779-2026-00637
IT WAS REPORTED WHILE USING BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED, THERE WAS 1 FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 12 OF 13.
9 April 2026 · Malfunction · BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED · BECTON DICKINSON & CO. (SPARKS) · report 1119779-2026-00635
IT WAS REPORTED WHILE USING BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED, THERE WAS 1 FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 10 OF 13.
9 April 2026 · Malfunction · BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED · BECTON DICKINSON & CO. (SPARKS) · report 1119779-2026-00636
IT WAS REPORTED WHILE USING BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED, THERE WAS 1 FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 11 OF 13.
9 April 2026 · Malfunction · BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED · BECTON DICKINSON & CO. (SPARKS) · report 1119779-2026-00627
IT WAS REPORTED WHILE USING BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED, THERE WAS 1 FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 3 OF 13.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code MNM, in Pathology, or approved in 1995. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.