BD PrepStain System

FDA Premarket Approval P970018 S037

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

A change in manufacturing process for bd surepath precoat slides

DeviceBD PrepStain System
Generic NameProcessor, Cervical Cytology Slide, Automated
ApplicantBD Diagnostic Systems
Date Received2021-01-21
Decision Date2021-02-16
PMAP970018
SupplementS037
Product CodeMKQ 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BD Diagnostic Systems 4025 Stirrup Creek Drive suite 400 durham, NC 27703

Supplemental Filings

Supplement NumberDateSupplement Type
P970018Original Filing
S037 2021-01-21 30-day Notice
S036 2017-10-10 Normal 180 Day Track No User Fee
S035 2017-07-17 Normal 180 Day Track No User Fee
S034 2016-05-31 30-day Notice
S033 2016-05-27 Real-time Process
S032 2015-03-26 Normal 180 Day Track
S031 2015-01-22 Normal 180 Day Track No User Fee
S030 2014-11-03 Normal 180 Day Track
S029 2013-11-15 30-day Notice
S028 2013-10-31 Normal 180 Day Track
S027 2013-09-30 Special (immediate Track)
S026
S025 2012-05-18 135 Review Track For 30-day Notice
S024 2011-08-24 Special (immediate Track)
S023 2011-06-27 Special (immediate Track)
S022
S021 2010-04-05 Real-time Process
S020 2010-02-18 30-day Notice
S019 2009-10-22 Normal 180 Day Track
S018 2009-09-08 Normal 180 Day Track No User Fee
S017 2009-06-11 Normal 180 Day Track
S016 2009-06-09 30-day Notice
S015 2009-05-27 Real-time Process
S014 2008-07-21 Real-time Process
S013
S012 2007-04-19 Special (immediate Track)
S011
S010 2005-09-01 Real-time Process
S009 2005-01-10 Real-time Process
S008
S007 2003-12-01 Normal 180 Day Track
S006 2003-03-24 Normal 180 Day Track
S005 2002-08-26 Normal 180 Day Track
S004 2002-07-02 Normal 180 Day Track
S003 2001-10-26 Real-time Process
S002 2000-12-01 Normal 180 Day Track
S001 2000-08-08 Real-time Process

NIH GUDID Devices

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