PMA P130007S016

Device

OneTouch Vibe™ Plus System

Applicant

Animas Corp.

PMA number

P130007

Supplement

S016

Product code

OYC

Decision date

2016-12-16

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 the OneTouch Vibe Plus System is indicated for continuous subcutaneous insulin infusion for the management of insulin-requiring diabetes. It can be used solely for continuous insulin delivery and as part of the OneTouch Vibe Plus System to receive and display continuous glucose measurements from the Dexcom G5® Sensor and Transmitter. The OneTouch Vibe Plus System's continuous glucose monitoring (CGM) is indicated for detecting trends and tracking patterns in persons (ages 2 and older) with diabetes, and is intended to complement, not replace, information obtained from standard home glucose monitoring devices. CGM aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of results from the Dexcom G5® Sensor and Transmitter should be based on the trends and patterns seen with several sequential readings over time. The System is intended for single patient use and requires a prescription.The Animas® Vibe® System’s continuous glucose monitoring (CGM) is indicated for detecting trends and tracking patterns in persons (age 2 and older) with diabetes, and is intended to complement, not replace, information obtained from standard home glucose monitoring devices. CGM aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of results from the Dexcom G5® Sensor and Transmitter should be based on the trends and patterns seen with several sequential readings over time.The System is intended for single patient use and requires a prescription.

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130007S016B.pdf" target="_new">Summary of Safety and Effectiveness</a>