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.
New injection molding equipment and tooling used for injection molding processes during manufacture of three components of the animas 2. 0 ml insulin cartridge. The insulin cartridge 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 | 2017-05-11 |
| Decision Date | 2017-06-09 |
| PMA | P130007 |
| Supplement | S026 |
| Product Code | OYC |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |