Gambro Prismaflex TPE2000 Set

FDA Premarket Approval P830063 S017

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 the extrusion process for the pump segment tubing of the prismaflex tpe 2000 set

DeviceGambro Prismaflex TPE2000 Set
Generic NameSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma
ApplicantBAXTER INTERNATIONAL, INC.
Date Received2020-07-29
Decision Date2020-08-27
PMAP830063
SupplementS017
Product CodeMDP 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BAXTER INTERNATIONAL, INC. 1 Baxter Pkwy. deerfield, IL 60015-4633

Supplemental Filings

Supplement NumberDateSupplement Type
P830063Original Filing
S017 2020-07-29 30-day Notice
S016 2020-03-05 Real-time Process
S015 2020-02-24 Special (immediate Track)
S014 2019-11-15 30-day Notice
S013
S012 2019-06-27 Real-time Process
S011
S010 2017-10-26 30-day Notice
S009 2016-12-02 30-day Notice
S008 2015-10-13 Special (immediate Track)
S007 2015-05-29 30-day Notice
S006 2007-10-09 Real-time Process
S005 2006-11-24 Normal 180 Day Track
S004 2001-11-13 Normal 180 Day Track
S003 2000-10-31 Real-time Process
S002 2000-01-18 Normal 180 Day Track
S001 1995-07-06 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
07332414111038 P830063 006

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