Guardian Connect System

Sensor, Glucose, Invasive

FDA Premarket Approval P160007 S028

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

Supplier of the glucose oxidase used in the fabrication of the enlite sensor and guardian sensor (3) moved their manufacturing facility from one location to another within the united kingdom.

DeviceGuardian Connect System
Classification NameSensor, Glucose, Invasive
Generic NameSensor, Glucose, Invasive
Date Received2019-10-17
Decision Date2019-11-15
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
S028 2019-10-17 30-day Notice
S027 2019-10-11 30-day Notice
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
S017 2019-04-03 30-day Notice
S016 2019-02-25 30-day Notice
S015 2019-02-11 30-day Notice
S013 2019-02-01 30-day Notice
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


Device IDPMASupp
00763000186333 P160007 000
20763000179629 P160007 000
00763000002596 P160007 000
00763000002602 P160007 000
00763000158392 P160007 000
00763000186333 P160007 000
00763000002596 P160007 000
00763000002602 P160007 000
00763000158392 P160007 000
00763000179601 P160007 000

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