Note: 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. |
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Device | Prismaflex TPE2000 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 | S018 |
Date Received | 04/19/2021 |
Decision Date | 07/16/2021 |
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 material composition change for a component of the Prismaflex TPE2000 Set, specifically the change to the PVC material used for the production of the fluid pump segments of the Prismaflex TPE 2000 Set. |
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