Guardian Connect System

FDA Premarket Approval P160007 S037

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 of intricon corporation (intricon red fox), 1260 red fox road, saint paul, mn as an alternative finished product manufacturing facility and intricon corporation grey fox (intricon grey fox), 1275 grey fox road arden hills, mn as an alternate final packaging process facility for the guardian link (3) and guardian connect transmitter. The transmitters are components of the minimed 630g system with smartguard, guardian connect system, and minimed 670g system. The submission also requested approval of process changes related to the new manufacturing facilities including a new inspection process and equipment

DeviceGuardian Connect System
Generic NameSensor, Glucose, Invasive
ApplicantMEDTRONIC MINIMED
Date Received2020-08-04
Decision Date2020-09-02
PMAP160007
SupplementS037
Product CodeMDS 
Advisory CommitteeClinical Chemistry
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC MINIMED 18000 Devonshire Street northridge, CA 91325-1219

Supplemental Filings

Supplement NumberDateSupplement Type
P160007Original Filing
S037 2020-08-04 30-day Notice
S036 2020-05-26 30-day Notice
S035
S034 2020-01-08 30-day Notice
S033 2019-11-29 30-day Notice
S032
S031 2019-11-27 30-day Notice
S030 2019-11-27 30-day Notice
S029
S028 2019-10-17 30-day Notice
S027 2019-10-11 30-day Notice
S026
S025 2019-08-21 30-day Notice
S024 2019-07-15 30-day Notice
S023 2019-06-19 30-day Notice
S022 2019-05-21 30-day Notice
S021 2019-05-17 30-day Notice
S020
S019
S018
S017 2019-04-03 30-day Notice
S016 2019-02-25 30-day Notice
S015 2019-02-11 30-day Notice
S014
S013 2019-02-01 30-day Notice
S012
S011 2018-11-02 30-day Notice
S010 2018-10-15 30-day Notice
S009 2018-07-09 30-day Notice
S008 2018-07-02 30-day Notice
S007 2018-06-19 30-day Notice
S006 2018-06-07 Special (immediate Track)
S005 2018-05-31 30-day Notice
S004 2018-05-18 Real-time Process
S003 2018-05-11 30-day Notice
S002 2018-03-29 30-day Notice
S001 2018-03-26 30-day Notice

NIH GUDID Devices

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