Guardian Connect system

FDA Premarket Approval P160007 S040

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 an update to product labeling to warn against a new interference by hydroxyurea to the continuous glucose monitoring (cgm) component of the system.

DeviceGuardian Connect system
Generic NameSensor, Glucose, Invasive
ApplicantMEDTRONIC MINIMED
Date Received2021-01-27
Decision Date2021-02-25
PMAP160007
SupplementS040
Product CodeMDS 
Advisory CommitteeClinical Chemistry
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC MINIMED 18000 Devonshire Street northridge, CA 91325-1219

Supplemental Filings

Supplement NumberDateSupplement Type
P160007Original Filing
S046 2022-11-04 30-day Notice
S045
S044 2022-04-01 30-day Notice
S043
S042 2021-11-17 Special (immediate Track)
S041 2021-09-20 30-day Notice
S040 2021-01-27 Special (immediate Track)
S039 2020-11-03 30-day Notice
S038
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

Device IDPMASupp
00763000186333 P160007 000
00763000455651 P160007 000
00763000408886 P160007 000
00763000408893 P160007 000
00763000455682 P160007 000
00763000455668 P160007 000
00763000455675 P160007 000
00763000516239 P160007 000
00763000399009 P160007 000
00763000398330 P160007 000
00763000285852 P160007 000
00763000179601 P160007 000
20763000179629 P160007 000
00763000002596 P160007 000
00763000002602 P160007 000
00763000158392 P160007 000
00763000348021 P160007 000
00763000388379 P160007 003
00763000381103 P160007 029
00763000381097 P160007 029
00763000337049 P160007 036
00763000337001 P160007 036
00763000388379 P160007 037
00763000388355 P160007 037

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