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.
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.
| Device | OneTouch Vibe™ Plus System |
| Classification Name | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor |
| Generic Name | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor |
| Applicant | ANIMAS CORP. |
| Date Received | 2016-06-06 |
| Decision Date | 2016-12-16 |
| Notice Date | 2016-12-20 |
| PMA | P130007 |
| Supplement | S016 |
| Product Code | OYC |
| Docket Number | 16M-4458 |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Panel Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ANIMAS CORP. 965 Chesterbrook Blvd. wayne, PA 19087 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130007 | Original Filing | |
| S036 | 2018-06-18 | 30-day Notice |
| S035 | 2018-03-20 | 30-day Notice |
| S034 | 2018-02-20 | 30-day Notice |
| S033 | 2018-01-30 | 30-day Notice |
| S032 | ||
| S031 | 2017-09-29 | 30-day Notice |
| S030 | ||
| S029 | 2017-07-18 | 30-day Notice |
| S028 | ||
| S027 | 2017-06-02 | 135 Review Track For 30-day Notice |
| S026 | 2017-05-11 | 30-day Notice |
| S025 | ||
| S024 | 2017-03-24 | 30-day Notice |
| S023 | 2017-03-22 | 30-day Notice |
| S022 | 2016-09-19 | Real-time Process |
| S021 | ||
| S020 | 2016-08-18 | 30-day Notice |
| S019 | 2016-07-29 | Real-time Process |
| S018 | 2016-07-26 | 30-day Notice |
| S017 | ||
| S016 | 2016-06-06 | Panel Track |
| S015 | 2016-05-02 | 30-day Notice |
| S014 | 2016-04-21 | Real-time Process |
| S013 | 2016-04-12 | 30-day Notice |
| S012 | 2016-04-07 | Real-time Process |
| S011 | 2016-03-17 | Real-time Process |
| S010 | 2016-02-05 | 30-day Notice |
| S009 | 2015-09-21 | 30-day Notice |
| S008 | 2015-08-20 | Real-time Process |
| S007 | 2015-07-21 | 30-day Notice |
| S006 | 2015-07-13 | 30-day Notice |
| S005 | 2015-07-06 | Real-time Process |
| S004 | 2015-04-30 | Panel Track |
| S003 | 2015-04-10 | 135 Review Track For 30-day Notice |
| S002 | 2015-03-26 | Real-time Process |
| S001 | 2015-01-23 | Real-time Process |