|
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 | S015 |
Date Received | 02/24/2020 |
Decision Date | 03/25/2020 |
Product Code |
MDP |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the following changes in the instructions for use:1) A labeling change to align the sterile symbol to current sterile fluid path description in the instructions for use of the Prismaflex TPE2000 set; and2) The addition of the following warning statement: Use only drugs compatible with plastics listed in the specifications section. Some plastics can be incompatible with drugs when in contact with solutions with pH > 10. |