Prismaflex TPE2000 Set

FDA Premarket Approval P830063 S019

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

To transfer the production of some components of the prismaflex tpe2000 set to alternate baxter locations

DevicePrismaflex TPE2000 Set
Generic NameSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma
ApplicantBAXTER INTERNATIONAL, INC.
Date Received2021-05-26
Decision Date2021-06-24
PMAP830063
SupplementS019
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
S019 2021-05-26 30-day Notice
S018
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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