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 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.
| Device | ANIMAS VIBE SYSTEM |
| Classification Name | Sensor, Glucose, Invasive |
| Generic Name | Sensor, Glucose, Invasive |
| Applicant | ANIMAS CORP. |
| Date Received | 2015-04-30 |
| Decision Date | 2015-12-24 |
| Notice Date | 2016-02-12 |
| PMA | P130007 |
| Supplement | S004 |
| Product Code | MDS |
| Docket Number | 16M-0120 |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |