Product code OZO
- Device name
- Automated Insulin Dosing , Threshold Suspend
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P150001S110 | Medtronic MiniMed 630G System | Medtronic Minimed | 2025-10-16 |
| P150001S109 | Guardian Sensor 3 | Medtronic Minimed | 2024-01-05 |
| P150001S108 | Guardian Sensor 3 | Medtronic Minimed | 2024-01-03 |
| P150001S107 | MiniMed 630G system | Medtronic Minimed | 2023-10-30 |
| P150001S104 | MiniMed 630G System | Medtronic Minimed | 2023-04-18 |
| P150001S105 | Medtronic MiniMed 630G System (MM630G) | Medtronic Minimed | 2023-03-13 |
| P150001S102 | MiniMed 630G System | Medtronic Minimed | 2022-12-16 |
| P150001S094 | Guardian Sensor 3 | Medtronic Minimed | 2022-12-16 |
| P150001S101 | MiniMed 630G System with SmartGuard, MiniMed 630G System with GS3, GS3 Transfer to MPROC | Medtronic Minimed | 2022-12-08 |
| P120010S142 | MiniMed Enlite Sensor | Medtronic, Inc. | 2022-12-08 |
| P150001S099 | Medtronic MiniMed 630G System with SmartGuard | Medtronic Minimed | 2022-10-17 |
| P150001S098 | Guardian Sensor (3) (MMT-7020), Enlite Sensor (MMT-7008) | Medtronic Minimed | 2022-04-29 |
| P120010S141 | Enlite Sensor (MMT-7008) | Medtronic, Inc. | 2022-04-29 |
| P150001S097 | Medtronic MiniMed 630G System | Medtronic Minimed | 2022-04-28 |
| P150001S096 | Medtronic MiniMed 630G insulin pump | Medtronic Minimed | 2022-04-28 |
| P150001S093 | MiniMed™ 630G System with SmartGuard™ | Medtronic Minimed | 2021-12-17 |
| P120010S140 | MiniMed™ 530G System | Medtronic, Inc. | 2021-12-17 |
| P150001S092 | MiniMed 630G System with SmartGuard Technology | Medtronic Minimed | 2021-10-05 |
| P150001S091 | MiniMed 630G System | Medtronic Minimed | 2021-07-07 |
| P150001S090 | MiniMed 630G System with SmartGuard | Medtronic Minimed | 2021-02-25 |
| P120010S139 | MiniMed 530G System | Medtronic, Inc. | 2021-02-25 |
| P150001S084 | MiniMed 630G System with Smart Guard | Medtronic Minimed | 2021-01-14 |
| P150001S089 | MiniMed 630G System | Medtronic Minimed | 2020-12-01 |
| P120010S138 | MiniMed 530G System | Medtronic, Inc. | 2020-12-01 |
| P150001S088 | MiniMed 630G System with SmartGuard | Medtronic Minimed | 2020-10-09 |
| P150001S087 | MiniMed 630G System | Medtronic Minimed | 2020-09-02 |
| P150001S086 | MiniMed 630G System with Smart Guard | Medtronic Minimed | 2020-06-25 |
| P150001S083 | MiniMed 630G Insulin Pump | Medtronic Minimed | 2020-04-16 |
| P150001S082 | Medtronic MiniMed 630G System | Medtronic Minimed | 2020-01-31 |
| P150001S081 | MiniMed 630G Insulin Pump | Medtronic Minimed | 2020-01-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00643169455535 | ENLiTE™ | MEDTRONIC MINIMED, INC. | 2023-07-20 |
| 00763000391065 | Guardian™ Link (3) | MEDTRONIC MINIMED, INC. | 2020-10-26 |
| 00763000391041 | Guardian™ Link (3) | MEDTRONIC XOMED, INC. | 2020-10-26 |
| 20763000337005 | Guardian™ Sensor (3) | MEDTRONIC MINIMED, INC. | 2020-07-10 |
| 10301937550154 | CONTOUR®NEXT | ASCENSIA DIABETES CARE US INC. | 2019-08-30 |
| 00763000283445 | MiniMed® 670G | MEDTRONIC MINIMED, INC. | 2019-08-29 |
| 00763000166540 | Guardian™ Link (3) | MEDTRONIC MINIMED, INC. | 2018-08-20 |
| 00763000164300 | MiniLink® REAL-Time | MEDTRONIC MINIMED, INC. | 2018-07-07 |
| 00763000157043 | MiniMed® 630G | MEDTRONIC MINIMED, INC. | 2018-07-05 |
| 00763000146849 | Guardian™ Link (3) | MEDTRONIC MINIMED, INC. | 2018-06-18 |
| 00763000117030 | Guardian ™ Sensor (3) | MEDTRONIC MINIMED, INC. | 2018-04-20 |
| 00763000096984 | MiniMed®670G | MEDTRONIC MINIMED, INC. | 2018-03-24 |
| 20643169786725 | Enlite ® | MEDTRONIC MINIMED, INC. | 2017-11-25 |
| 10301937278706 | CONTOUR® NEXT | ASCENSIA DIABETES CARE US INC. | 2017-11-03 |
| 10301937277358 | CONTOUR® NEXT | ASCENSIA DIABETES CARE US INC. | 2017-11-03 |
| 00643169955691 | Guardian™ Link (3) | MEDTRONIC MINIMED, INC. | 2017-10-30 |
| 00643169704060 | Guardian ™ Sensor (3) | MEDTRONIC MINIMED, INC. | 2017-04-03 |
| 00643169946057 | MiniMed® 670G | MEDTRONIC MINIMED, INC. | 2017-04-03 |
| 00643169164413 | Sen-Serter© | MEDTRONIC MINIMED, INC. | 2016-10-01 |
| 00643169283183 | Medtronic Guardian™ Link | MEDTRONIC MINIMED, INC. | 2016-09-23 |
| 00301937283352 | CONTOUR® NEXT | ASCENSIA DIABETES CARE US INC. | 2016-09-16 |
| 00301936262013 | CONTOUR® NEXT LINK 2.4 | ASCENSIA DIABETES CARE US INC. | 2016-08-25 |
| 10301937313100 | CONTOUR® NEXT | ASCENSIA DIABETES CARE US INC. | 2016-08-25 |
| 10301937312219 | CONTOUR® NEXT | ASCENSIA DIABETES CARE US INC. | 2016-08-25 |
| 10301937311502 | CONTOUR® NEXT | ASCENSIA DIABETES CARE US INC. | 2016-08-25 |
| 10301937310253 | CONTOUR® NEXT | ASCENSIA DIABETES CARE US INC. | 2016-08-25 |
| 10301937309509 | CONTOUR® NEXT | ASCENSIA DIABETES CARE US INC. | 2016-08-25 |
| 10301937308502 | CONTOUR® NEXT | ASCENSIA DIABETES CARE US INC. | 2016-08-25 |
| 00643169462724 | Enlite™ Serter | MEDTRONIC MINIMED, INC. | 2016-08-14 |
| 00643169246478 | Enlite® Serter | MEDTRONIC MINIMED, INC. | 2014-09-24 |