GAMBRO FIBER PLASMAFILTER

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma

FDA Premarket Approval P830063

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the gambro fiber plasmafilter pp. This device is indicated for use in performing therapeutic plasma separation from whole blood in a clinical setting to remove circulation plasma components or protein bound toxins.

DeviceGAMBRO FIBER PLASMAFILTER
Classification NameSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma
Generic NameSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma
ApplicantBAXTER INTERNATIONAL, INC.
Date Received1983-10-04
Decision Date1986-05-27
Notice Date1986-07-07
PMAP830063
SupplementS
Product CodeMDP
Docket Number86M-0250
Advisory CommitteeGastroenterology/Urology
Expedited ReviewNo
Combination Product No
Applicant Address BAXTER INTERNATIONAL, INC. 1 Baxter Pkwy. deerfield, IL 60015-4633
Post-Approval Study:Show Report Schedule and Study Progress

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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