|
Device | Gambro Prismaflex TPE 2000 Set |
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 |
Supplement Number | S020 |
Date Received | 11/09/2021 |
Decision Date | 01/27/2022 |
Product Code |
MDP |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change in the polyvinyl chloride (PVC) material used for the production of the joint connectors in the Prismaflex TPE2000 Set. |