Gambro Prismaflex TPE 2000 Set

FDA Premarket Approval P830063 S024

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

DeviceGambro Prismaflex TPE 2000 Set
Generic NameSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma
ApplicantBAXTER INTERNATIONAL, INC.1 Baxter Pkwy.deerfield, IL 60015-4633 PMA NumberP830063 Supplement NumberS024 Date Received10/18/2022 Decision Date11/08/2022 Product Code MDP  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-18
Decision Date2022-11-08
PMAP830063
SupplementS024
Product CodeMDP 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressBAXTER INTERNATIONAL, INC.
1 Baxter Pkwy.
deerfield, IL 60015-4633 PMA NumberP830063 Supplement NumberS024 Date Received10/18/2022 Decision Date11/08/2022 Product Code MDP  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
transfer Of The Manufacturing Process Of The Bubble Up And The Bubble Down Components Of The Prismaflex TPE2000 Set To The Borla Supplier Manufacturing Facility

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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