|
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 | S023 |
Date Received | 03/29/2022 |
Decision Date | 04/07/2022 |
Product Code |
MDP |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Transfer of the manufacturing process of the twin tube component of the Prismaflex TPE2000 set to an in-house supplier. |