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PMA P130007S027

Device
Animas Vibe System
Applicant
Animas Corp.
PMA number
P130007
Supplement
S027
Product code
OYC
Decision date
2017-10-27
Classification
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
Generic name
Pump, infusion, insulin, to be used with invasive glucose sensor
Approval order statement
Approval for changes to the manufacturer of two fastener screws and the lead screw used in the pump drive mechanism for the Animas Vibe Insulin pump. The Animas Vibe Insulin pump is a component of the Animas Vibe System.

Current openFDA PMA Record#

Device
Animas Vibe System
Applicant
Animas Corp.
PMA number
P130007
Supplement
S027
Product code
OYC
Generic name
Pump, infusion, insulin, to be used with invasive glucose sensor
Decision date
2017-10-27
Decision code
APPR
Date received
2017-06-02
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for changes to the manufacturer of two fastener screws and the lead screw used in the pump drive mechanism for the Animas Vibe Insulin pump. The Animas Vibe Insulin pump is a component of the Animas Vibe System.