ANIMAS VIBE SYSTEM

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Premarket Approval P130007 S020

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

Addition of a second main board assembly line for the animas vibe insulin pump at the supplier. The vibe insulin pump is a component of the animas vibe system.

DeviceANIMAS VIBE SYSTEM
Classification NamePump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
Generic NamePump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
ApplicantANIMAS CORP.
Date Received2016-08-18
Decision Date2016-09-15
PMAP130007
SupplementS020
Product CodeOYC
Advisory CommitteeClinical Chemistry
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ANIMAS CORP. 965 Chesterbrook Blvd. wayne, PA 19087

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.