ANIMAS VIBE SYSTEM

Sensor, Glucose, Invasive

FDA Premarket Approval P130007 S006

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

Change to the molding press equipment for several animas vibe pump components. The animas vibe pump is a component of the animas vibe system.

DeviceANIMAS VIBE SYSTEM
Classification NameSensor, Glucose, Invasive
Generic NameSensor, Glucose, Invasive
ApplicantANIMAS CORP.
Date Received2015-07-13
Decision Date2015-08-10
PMAP130007
SupplementS006
Product CodeMDS
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

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