Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | ANIMAS VIBE SYSTEM |
Generic Name | Pump, infusion, insulin, to be used with invasive glucose sensor |
Applicant | ANIMAS CORP. 965 CHESTERBROOK BLVD. WAYNE, PA 19087 |
PMA Number | P130007 |
Date Received | 04/17/2013 |
Decision Date | 11/25/2014 |
Withdrawal Date
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06/11/2020 |
Product Codes |
MDS OYC |
Docket Number | 14M-2246 |
Notice Date | 12/18/2014 |
Advisory Committee |
Clinical Chemistry |
Expedited Review Granted? | No |
Combination Product | No |
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 |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S018 S019 S020 S022 S023 S024 S026 S027 S029 S031 S033 S034 S035 S036 |
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