Prismaflex TPE2000 Set

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma

FDA Premarket Approval P830063 S012

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 the use of the prismaflex tpe2000 set with the prismax control unit (version 2) and modifications to the instructions for use.

DevicePrismaflex TPE2000 Set
Classification NameSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma
Generic NameSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma
ApplicantBAXTER INTERNATIONAL, INC.
Date Received2019-06-27
Decision Date2019-09-18
PMAP830063
SupplementS012
Product CodeMDP
Advisory CommitteeGastroenterology/Urology
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address BAXTER INTERNATIONAL, INC. 1 Baxter Pkwy. deerfield, IL 60015-4633

Supplemental Filings

Supplement NumberDateSupplement Type
P830063Original Filing
S024 2022-10-18 30-day Notice
S023 2022-03-29 30-day Notice
S022 2022-03-02 30-day Notice
S021
S020 2021-11-09 Real-time Process
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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