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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceANIMAS VIBE SYSTEM
Generic NameSensor, glucose, invasive
ApplicantANIMAS CORP.
965 CHESTERBROOK BLVD.
WAYNE, PA 19087
PMA NumberP130007
Supplement NumberS004
Date Received04/30/2015
Decision Date12/24/2015
Withdrawal Date 06/11/2020
Product Codes MDS OYC 
Docket Number 16M-0120
Notice Date 02/12/2016
Advisory Committee Clinical Chemistry
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ANIMAS VIBE SYSTEM. THE ANIMAS® VIBE SYSTEM CONSISTS OF THE ANIMAS VIBE INSULIN PUMP PAIRED WITH THE DEXCOM G4 PLATINUM CGM SENSOR AND TRANSMITTER.THE ANIMAS VIBE INSULIN PUMP IS INTENDED FOR THE CONTINUOUS SUBCUTANEOUS INFUSION OF INSULIN FOR THE MANAGEMENT OF INSULIN-REQUIRING DIABETES. IT CAN BE USED SOLELY FOR CONTINUOUS INSULIN DELIVERY OR 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 SYSTEMS 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 G4 PLATINUM SENSOR AND TRANSMITTER SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.THE ANIMAS VIBE SYSTEM IS INTENDED FOR SINGLE PATIENT USE IN PERSONS AGE 2 AND OLDER AND REQUIRES A PRESCRIPTION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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