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Device | GAMBRO FIBER PLASMAFILTER |
Generic Name | Separator for therapeutic purposes, membrane automated blood cell/plasma |
Applicant | BAXTER INTERNATIONAL, INC. 1 BAXTER PKWY. DEERFIELD, IL 60015-4633 |
PMA Number | P830063 |
Date Received | 10/04/1983 |
Decision Date | 05/27/1986 |
Product Code |
MDP |
Docket Number | 86M-0250 |
Notice Date | 07/07/1986 |
Advisory Committee |
Gastroenterology/Urology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |
Supplements: |
S007 S001 S002 S003 S004 S005 S006 S008 S009 S010 S012 S013 S014 S015 S016 S017 S018 S019 S020 S022 S023 S024 S025 S026 S027 |