FDA.reportPublic FDA data

PMA P080012S041

Device
Prometra Programmable Infusion Pump System
Applicant
Infusyn Therapeutics, LLC
PMA number
P080012
Supplement
S041
Product code
LKK
Decision date
2017-05-31
Classification
Pump, Infusion, Implanted, Programmable
Generic name
Pump, infusion, implanted, programmable
Approval order statement
Approval for the addition of a dimensional measurement to the current inspection procedure for the Flow Activated Safety Valve (FAV) Access Port Body component to measure the counter-sink depth of the O-ring sealing surface, as specified in change ECO 16-80.

Current openFDA PMA Record#

Device
Prometra Programmable Infusion Pump System
Applicant
Infusyn Therapeutics, LLC
PMA number
P080012
Supplement
S041
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2017-05-31
Decision code
APPR
Date received
2017-05-01
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for the addition of a dimensional measurement to the current inspection procedure for the Flow Activated Safety Valve (FAV) Access Port Body component to measure the counter-sink depth of the O-ring sealing surface, as specified in change ECO 16-80.