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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameANIMAS VIBE SYSTEM
Classification Namepump, infusion, insulin, to be used with invasive glucose sensor
ApplicantANIMAS CORP.
PMA NumberP130007
Date Received04/25/2013
Decision Date11/25/2014
Product Code
OYC[ Registered Establishments with OYC ]
Docket Number 14M-2246
Notice Date 12/18/2014
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the animas vibe system. This device is indicated for: the animas® vibe¿ system consists of the animas® vibe¿ insulin pump paired with the dexcom g4 platinum sensor and transmitter. The animas® vibe¿ insulin pump 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 animas® vibe¿ system to receive and display continuous glucose measurements from the dexcom g4 platinum sensor and transmitter. The animas® vibe¿ system's continuous glucose monitoring (cgm) is indicated for detecting trends and tracking patterns in persons (age 18 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 g4 platinum 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.
Approval Order Approval Order
Supplements: S001 S002 
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