ANIMAS VIBE SYSTEM

Sensor, Glucose, Invasive

FDA Premarket Approval P130007 S004

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.

Pre-market Approval Supplement Details

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.

DeviceANIMAS VIBE SYSTEM
Classification NameSensor, Glucose, Invasive
Generic NameSensor, Glucose, Invasive
ApplicantANIMAS CORP.
Date Received2015-04-30
Decision Date2015-12-24
Notice Date2016-02-12
PMAP130007
SupplementS004
Product CodeMDS
Docket Number16M-0120
Advisory CommitteeClinical Chemistry
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
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

Supplemental Filings

Supplement NumberDateSupplement Type
P130007Original 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

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