| 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. |
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| Device | OneTouch Vibe™ Plus System |
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| Generic Name | Pump, infusion, insulin, to be used with invasive glucose sensor |
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| Applicant | Animas Corp.
965 Chesterbrook Blvd.
Wayne, PA 19087 |
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| PMA Number | P130007 |
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| Supplement Number | S016 |
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| Date Received | 06/06/2016 |
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| Decision Date | 12/16/2016 |
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| Withdrawal Date | 06/11/2020 |
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| Product Codes |
MDS OYC |
| Docket Number | 16M-4458 |
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| Notice Date | 12/20/2016 |
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| Advisory Committee |
Clinical Chemistry |
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| Supplement Type | Panel Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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