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 modifications to the attachment method that secures the disposable housing to the adhesive patch of the sensor pod of dexcom’s g4 platinum/g5 mobile sensor component, which required modifications to the disposable housing, implementation of a semi-automated heat staking machine and a change to the inspection method. The sensor is a component of the animas vibe system.
| Device | ANIMAS VIBE 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 | 2016-07-29 |
| Decision Date | 2016-11-05 |
| PMA | P130007 |
| Supplement | S019 |
| Product Code | OYC |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ANIMAS CORP. 965 Chesterbrook Blvd. wayne, PA 19087 |
| 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 |