FDA.reportPublic FDA data

PMA P080012S040

Device
Prometra Programmable Infusion Pump System
Applicant
Infusyn Therapeutics, LLC
PMA number
P080012
Supplement
S040
Product code
LKK
Decision date
2019-01-28
Classification
Pump, Infusion, Implanted, Programmable
Generic name
Pump, infusion, implanted, programmable
Approval order statement
Approval for updates to the hardware (Clinician Programmer Model #13828), software and labeling of the Clinician Programmer and modifications to the software and labeling of the Patient Therapy Controller (PTC) for the Prometra Programmable Infusion Pump System.

Current openFDA PMA Record#

Device
Prometra Programmable Infusion Pump System
Applicant
Infusyn Therapeutics, LLC
PMA number
P080012
Supplement
S040
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2019-01-28
Decision code
APPR
Date received
2017-04-12
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for updates to the hardware (Clinician Programmer Model #13828), software and labeling of the Clinician Programmer and modifications to the software and labeling of the Patient Therapy Controller (PTC) for the Prometra Programmable Infusion Pump System.