FDA.reportPublic FDA data

PMA P830063S016

Device
PRISMAFLEX TPE 2000 Set
Applicant
Vantive US Healthcare, LLC
PMA number
P830063
Supplement
S016
Product code
MDP
Decision date
2020-05-23
Generic name
Separator for therapeutic purposes, membrane automated blood cell/plasma
Approval order statement
Approval for a minor change to the raw material used for the header cap component, which is part of the plasmafilter subassembly of the PRISMAFLEX TPE2000 Set.

Current openFDA PMA Record#

Device
PRISMAFLEX TPE 2000 Set
Applicant
Vantive US Healthcare, LLC
PMA number
P830063
Supplement
S016
Product code
MDP
Generic name
Separator for therapeutic purposes, membrane automated blood cell/plasma
Decision date
2020-05-23
Decision code
APPR
Date received
2020-03-05
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a minor change to the raw material used for the header cap component, which is part of the plasmafilter subassembly of the PRISMAFLEX TPE2000 Set.