FDA.reportPublic FDA data

PMA P830063S025

Device
Prismaflex TPE2000
Applicant
Vantive US Healthcare, LLC
PMA number
P830063
Supplement
S025
Product code
MDP
Decision date
2023-03-29
Classification
Gastroenterology, Urology
Generic name
Separator for therapeutic purposes, membrane automated blood cell/plasma
Approval order statement
Changing the transfer of the molding activity of the female luer lock 5.5 (current part number: 9200973400, new part number: 60023196) that is present on the Prismaflex TPE 2000 set, from HMC, a third-party supplier to the Baxter manufacturing plant Malta.

Current openFDA PMA Record#

Device
Prismaflex TPE2000
Applicant
Vantive US Healthcare, LLC
PMA number
P830063
Supplement
S025
Product code
MDP
Generic name
Separator for therapeutic purposes, membrane automated blood cell/plasma
Decision date
2023-03-29
Decision code
OK30
Date received
2023-03-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changing the transfer of the molding activity of the female luer lock 5.5 (current part number: 9200973400, new part number: 60023196) that is present on the Prismaflex TPE 2000 set, from HMC, a third-party supplier to the Baxter manufacturing plant Malta.