FDA.reportPublic FDA data

PMA P080012S064

Device
Prometra Programmable Infusion Pump System
Applicant
Infusyn Therapeutics, LLC
PMA number
P080012
Supplement
S064
Product code
LKK
Decision date
2020-01-15
Generic name
Pump, infusion, implanted, programmable
Approval order statement
Approval for minor software changes (correction of firmware errors) to bring the Prometra II Programmable Pumps (20mL and 40mL) back into specification to match the performance as reflected in the original software requirements.

Current openFDA PMA Record#

Device
Prometra Programmable Infusion Pump System
Applicant
Infusyn Therapeutics, LLC
PMA number
P080012
Supplement
S064
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2020-01-15
Decision code
APPR
Date received
2019-12-27
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for minor software changes (correction of firmware errors) to bring the Prometra II Programmable Pumps (20mL and 40mL) back into specification to match the performance as reflected in the original software requirements.