Guardian Sensor (3) (MMT-7020)

FDA Premarket Approval P160007 S044

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

DeviceGuardian Sensor (3) (MMT-7020)
Generic NameSensor, Glucose, Invasive
ApplicantMEDTRONIC MINIMED18000 Devonshire Streetnorthridge, CA 91325-1219 PMA NumberP160007 Supplement NumberS044 Date Received04/01/2022 Decision Date04/29/2022 Product Code MDS  Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-01
Decision Date2022-04-29
PMAP160007
SupplementS044
Product CodeMDS 
Advisory CommitteeClinical Chemistry
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressMEDTRONIC MINIMED
18000 Devonshire Street
northridge, CA 91325-1219 PMA NumberP160007 Supplement NumberS044 Date Received04/01/2022 Decision Date04/29/2022 Product Code MDS  Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For Addition Of An Alternate Bioburden And Sterility Contract Testing Laboratory For The Enlite Sensor And The Guardian Sensor (3). The Enlite Sensor Is A Components Of The MiniMed 530G, 630G, Paradigm Real-Time Revel, And IPro2 CGM Systems. The Guardian Sensor (3) Is A Component Of The MiniMed 630G, Guardian Connect, 670G And 770G Systems

Supplemental Filings

Supplement NumberDateSupplement Type
P160007Original Filing
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
00763000455675 P160007 000
00763000455668 P160007 000
00763000455682 P160007 000
00763000455651 P160007 000
00763000348021 P160007 000
00763000408886 P160007 000
00763000408893 P160007 000
00763000516239 P160007 000
00763000002596 P160007 000
20763000179629 P160007 000
00763000179601 P160007 000
00763000002602 P160007 000
00763000285852 P160007 000
00763000398330 P160007 000
00763000399009 P160007 000
00763000158392 P160007 000
00763000381097 P160007 029
00763000381103 P160007 029
00763000337001 P160007 036
00763000337049 P160007 036
00763000388379 P160007 037

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