FDA.reportPublic FDA data

PMA P080012S067

Device
Prometra Programmable Infusion Pump System
Applicant
Infusyn Therapeutics, LLC
PMA number
P080012
Supplement
S067
Product code
LKK
Decision date
2020-10-29
Generic name
Pump, infusion, implanted, programmable
Approval order statement
Approval for change to implement a software update of the Clinician Programmer Application Software (2.01.6) to improve Bluetooth connection reliability in Clinician Programmer REF 13828.

Current openFDA PMA Record#

Device
Prometra Programmable Infusion Pump System
Applicant
Infusyn Therapeutics, LLC
PMA number
P080012
Supplement
S067
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2020-10-29
Decision code
APPR
Date received
2020-07-31
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for change to implement a software update of the Clinician Programmer Application Software (2.01.6) to improve Bluetooth connection reliability in Clinician Programmer REF 13828.