MiniMed 630G System with SmartGuard, MiniMed 630G System with GS3, GS3 Transfer to MPROC

FDA Premarket Approval P150001 S101

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

DeviceMiniMed 630G System with SmartGuard, MiniMed 630G System with GS3, GS3 Transfer to MPROC
Generic NameAutomated Insulin Dosing , Threshold Suspend
ApplicantMEDTRONIC MINIMED18000 Devonshire Stnorthridge, CA 91325 PMA NumberP150001 Supplement NumberS101 Date Received11/04/2022 Decision Date12/08/2022 Product Code OZO  Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-11-04
Decision Date2022-12-08
PMAP150001
SupplementS101
Product CodeOZO 
Advisory CommitteeClinical Chemistry
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressMEDTRONIC MINIMED
18000 Devonshire St
northridge, CA 91325 PMA NumberP150001 Supplement NumberS101 Date Received11/04/2022 Decision Date12/08/2022 Product Code OZO  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  
addition Of A New Supplier For The Thermoformed Packaging Tray 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
P150001Original Filing
S102 2022-11-16 Special (immediate Track)
S101 2022-11-04 30-day Notice
S100
S099 2022-09-14 Special (immediate Track)
S098 2022-04-01 30-day Notice
S097 2022-03-30 30-day Notice
S096 2022-03-29 30-day Notice
S095
S094
S093 2021-11-17 Special (immediate Track)
S092 2021-09-20 30-day Notice
S091 2021-06-29 30-day Notice
S090 2021-01-27 Special (immediate Track)
S089 2020-11-03 30-day Notice
S088 2020-08-28 Real-time Process
S087 2020-08-04 30-day Notice
S086 2020-05-26 30-day Notice
S085
S084
S083 2020-03-30 30-day Notice
S082 2020-01-08 30-day Notice
S081 2019-12-23 30-day Notice
S080 2019-11-29 30-day Notice
S079 2019-11-27 30-day Notice
S078 2019-11-27 30-day Notice
S077 2019-10-17 30-day Notice
S076 2019-10-11 30-day Notice
S075 2019-09-30 30-day Notice
S074
S073 2019-08-21 30-day Notice
S072 2019-07-15 30-day Notice
S071 2019-06-19 30-day Notice
S070 2019-06-13 30-day Notice
S069 2019-05-21 30-day Notice
S068 2019-05-17 30-day Notice
S067
S066
S065
S064 2019-04-03 30-day Notice
S063 2019-04-01 30-day Notice
S062 2019-02-25 30-day Notice
S061 2019-02-11 30-day Notice
S060
S059 2019-02-01 30-day Notice
S058 2019-01-22 30-day Notice
S057
S056 2018-11-07 30-day Notice
S055 2018-11-07 30-day Notice
S054 2018-11-02 30-day Notice
S053 2018-10-15 30-day Notice
S052 2018-08-31 Real-time Process
S051 2018-07-23 30-day Notice
S050 2018-07-23 Normal 180 Day Track
S049 2018-07-09 30-day Notice
S048 2018-07-02 30-day Notice
S047 2018-06-19 30-day Notice
S046 2018-06-07 Special (immediate Track)
S045 2018-06-04 30-day Notice
S044 2018-05-11 30-day Notice
S043 2018-03-29 30-day Notice
S042 2018-03-26 30-day Notice
S041 2018-03-12 30-day Notice
S040 2018-02-23 30-day Notice
S039 2018-02-09 Real-time Process
S038 2018-02-07 30-day Notice
S037 2018-01-31 30-day Notice
S036 2018-01-30 30-day Notice
S035 2018-01-29 30-day Notice
S034 2018-01-29 30-day Notice
S033 2018-01-23 Special (immediate Track)
S032 2017-12-22 30-day Notice
S031 2017-11-30 Real-time Process
S030 2017-11-24 30-day Notice
S029
S028 2017-10-30 Normal 180 Day Track
S027 2017-10-30 30-day Notice
S026 2017-10-10 30-day Notice
S025 2017-10-06 30-day Notice
S024 2017-09-29 30-day Notice
S023 2017-09-14 30-day Notice
S022 2017-08-04 Real-time Process
S021 2017-08-02 Panel Track
S020 2017-07-21 Real-time Process
S019 2017-07-17 30-day Notice
S018
S017 2017-06-02 Special (immediate Track)
S016 2017-05-30 30-day Notice
S015 2017-05-08 30-day Notice
S014 2017-04-10 30-day Notice
S013 2017-04-07 Real-time Process
S012 2017-03-31 30-day Notice
S011 2017-03-24 30-day Notice
S010
S009 2016-12-23 Real-time Process
S008 2016-12-14 Normal 180 Day Track
S007 2016-12-12 30-day Notice
S006 2016-11-28 30-day Notice
S005 2016-11-28 30-day Notice
S004 2016-11-02 30-day Notice
S003 2016-10-24 Real-time Process
S002 2016-10-14 30-day Notice
S001 2016-09-02 30-day Notice

NIH GUDID Devices

Device IDPMASupp
0193-6262-01 P150001 000
00643169283183 P150001 000
00643169290822 P150001 000
00643169656840 P150001 000
00643169752726 P150001 000
00643169800403 P150001 000
00643169864672 P150001 000
00643169873834 P150001 000
00643169873841 P150001 000
00301936260019 P150001 000
00643169878648 P150001 001
00643169455535 P150001 007
00763000047665 P150001 013
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20763000017556 P150001 020
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00763000367060 P150001 083
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00763000367091 P150001 083

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