FDA.reportPublic FDA data

PMA P830063S014

Device
PRISMAFLEX TPE2000
Applicant
Vantive US Healthcare, LLC
PMA number
P830063
Supplement
S014
Product code
MDP
Decision date
2019-12-11
Generic name
Separator for therapeutic purposes, membrane automated blood cell/plasma
Approval order statement
Addition of an anti-error tubing connector feature to the support plate of the Prismaflex TPE2000 Set and a move of the manufacturing of several set components (e.g., striped tubes, luer components, and injection sites) to Marsa, Malta from Medolla, Italy.

Current openFDA PMA Record#

Device
PRISMAFLEX TPE2000
Applicant
Vantive US Healthcare, LLC
PMA number
P830063
Supplement
S014
Product code
MDP
Generic name
Separator for therapeutic purposes, membrane automated blood cell/plasma
Decision date
2019-12-11
Decision code
OK30
Date received
2019-11-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of an anti-error tubing connector feature to the support plate of the Prismaflex TPE2000 Set and a move of the manufacturing of several set components (e.g., striped tubes, luer components, and injection sites) to Marsa, Malta from Medolla, Italy.