PMA P130007S004
- Device
- ANIMAS VIBE SYSTEM
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S004
- Product code
- MDS
- Decision date
- 2015-12-24
- Classification
- Sensor, Glucose, Invasive
- Generic name
- Sensor, glucose, invasive
- 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130007S004B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- ANIMAS VIBE SYSTEM
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S004
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2015-12-24
- Decision code
- APPR
- Date received
- 2015-04-30
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.