MiniMed 670G System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Premarket Approval P160017 S075

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.

DeviceMiniMed 670G System
Classification NameAutomated Insulin Dosing Device System, Single Hormonal Control
Generic NameAutomated Insulin Dosing Device System, Single Hormonal Control
ApplicantMEDTRONIC MINIMED, INC.
Date Received2019-10-17
Decision Date2019-11-15
PMAP160017
SupplementS075
Product CodeOZP
Advisory CommitteeClinical Chemistry
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC MINIMED, INC. 18000 Devonshire Street northridge, CA 91325

Supplemental Filings

Supplement NumberDateSupplement Type
P160017Original Filing
S075 2019-10-17 30-day Notice
S074 2019-10-11 30-day Notice
S073 2019-09-30 30-day Notice
S072
S071
S070 2019-08-21 30-day Notice
S069 2019-07-15 30-day Notice
S068
S067 2019-06-19 30-day Notice
S066 2019-06-13 30-day Notice
S065 2019-05-21 30-day Notice
S064 2019-05-17 30-day Notice
S063
S062
S061
S060 2019-04-03 30-day Notice
S059 2019-04-01 30-day Notice
S058 2019-02-25 30-day Notice
S057 2019-02-11 30-day Notice
S056
S055 2019-02-01 30-day Notice
S054 2019-01-22 30-day Notice
S053 2018-11-02 30-day Notice
S052 2018-10-15 30-day Notice
S051 2018-08-31 Real-time Process
S050 2018-08-07 Normal 180 Day Track No User Fee
S049 2018-07-23 30-day Notice
S048 2018-07-23 Normal 180 Day Track
S047 2018-07-09 30-day Notice
S046 2018-07-02 30-day Notice
S045 2018-06-19 30-day Notice
S044 2018-06-07 Special (immediate Track)
S043 2018-06-04 30-day Notice
S042 2018-05-11 30-day Notice
S041 2018-03-29 30-day Notice
S040 2018-03-26 30-day Notice
S039 2018-03-12 30-day Notice
S038 2018-02-23 30-day Notice
S037 2018-02-09 Real-time Process
S036 2018-02-07 30-day Notice
S035 2018-01-31 30-day Notice
S034 2018-01-30 30-day Notice
S033 2018-01-29 30-day Notice
S032 2018-01-29 30-day Notice
S031 2018-01-26 Panel Track
S030 2018-01-23 Special (immediate Track)
S029 2017-12-22 30-day Notice
S028 2017-11-30 Real-time Process
S027 2017-11-24 Normal 180 Day Track No User Fee
S026 2017-11-24 30-day Notice
S025
S024 2017-10-10 30-day Notice
S023 2017-10-06 30-day Notice
S022
S021 2017-09-29 30-day Notice
S020 2017-09-27 Normal 180 Day Track
S019 2017-09-14 30-day Notice
S018 2017-08-04 Real-time Process
S017 2017-08-02 Panel Track
S016 2017-07-21 Real-time Process
S015
S014 2017-06-02 Special (immediate Track)
S013 2017-05-08 30-day Notice
S012 2017-04-10 30-day Notice
S011 2017-03-31 30-day Notice
S010 2017-03-24 30-day Notice
S009
S008 2016-12-30 Real-time Process
S007 2016-11-28 30-day Notice
S006 2016-11-28 30-day Notice
S005 2016-11-02 30-day Notice
S004 2016-10-27 Normal 180 Day Track No User Fee
S003 2016-10-26 Normal 180 Day Track
S002 2016-10-14 30-day Notice
S001 2016-10-12 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00643169980525 P160017 000
00643169946057 P160017 000
00643169946040 P160017 000
00643169939219 P160017 000
00643169939202 P160017 000
00643169980525 P160017 000
00763000293871 P160017 000
00643169939202 P160017 000
00643169946040 P160017 000
00643169946057 P160017 000
00643169939219 P160017 000
00643169704060 P160017 003
00643169955684 P160017 003
00643169955691 P160017 003
00643169955684 P160017 003
00643169955691 P160017 003
00643169704060 P160017 003
20643169704057 P160017 003
20643169975105 P160017 003
20643169975105 P160017 003
20643169704057 P160017 003
00763000146849 P160017 008
00763000146849 P160017 008
00763000146856 P160017 008
00763000146856 P160017 008
00763000140779 P160017 017
00763000157050 P160017 017
20763000157603 P160017 017
20763000140940 P160017 017
20763000157603 P160017 017
20763000140940 P160017 017
00763000157050 P160017 017
00763000140779 P160017 017
00763000166540 P160017 017
00763000166564 P160017 017
00763000157616 P160017 017
00763000166540 P160017 017
00763000157616 P160017 017
00763000166564 P160017 017
00763000075453 P160017 019
00763000075460 P160017 019
00763000072537 P160017 019
00763000075453 P160017 019
00763000075460 P160017 019
00763000072537 P160017 019
00763000090203 P160017 020
00763000096984 P160017 020
00763000090203 P160017 020
00763000096984 P160017 020
00763000173043 P160017 028
00763000166526 P160017 028
00763000179649 P160017 028
00763000166526 P160017 028
00763000173043 P160017 028
00763000179649 P160017 028
20763000118864 P160017 037
00763000117030 P160017 037
20763000118864 P160017 037
00763000117030 P160017 037
00763000215545 P160017 048
00763000215538 P160017 048
00763000215545 P160017 048
00763000215538 P160017 048
00763000256838 P160017 051
00763000256821 P160017 051
00763000278427 P160017 051
00763000293888 P160017 061

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.