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 a change to the animas vibe system labeling to specify compatibility with onetouch infusion sets.
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 | 2016-09-19 |
Decision Date | 2016-11-05 |
PMA | P130007 |
Supplement | S022 |
Product Code | OYC |
Advisory Committee | Clinical Chemistry |
Supplement Type | Real-time Process |
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 |
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 |