PAPNET (R) TESTING SYSTEM

FDA Premarket Approval P940029 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 specific computer hardware and software changes for the review station component of the papnet testing system.

DevicePAPNET (R) TESTING SYSTEM
Generic NameReader, Cervical Cytology Slide, Automated
ApplicantBD DIAGNOSTICS
Date Received1996-12-23
Decision Date1997-06-25
PMAP940029
SupplementS003
Product CodeMNM 
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address BD DIAGNOSTICS 4025 Stirrup Creek Drive suite 400 durham, NC 27703

Supplemental Filings

Supplement NumberDateSupplement Type
P940029Original Filing
S003 1996-12-23 Normal 180 Day Track
S002 1996-04-01 Normal 180 Day Track
S001 1996-01-31 Normal 180 Day Track

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