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 |
|---|---|---|---|
| P150001S111 | Medtronic MiniMed 630G System with Guardian Sensor (3); Guardian Sensor (3) Transfer to MPROC | Medtronic Minimed | 2026-07-21 |
| P120010S144 | Enlite Sensor | Medtronic, Inc. | 2026-07-21 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00643169164413 | Sen-Serter© | MEDTRONIC MINIMED, INC. | 2016-10-01 |
| 00613994933072 | Enlite™ Serter | MEDTRONIC MINIMED, INC. | 2016-08-14 |
| 00643169246577 | ENLITE® | MEDTRONIC MINIMED, INC. | 2014-09-24 |
| 00643169246478 | Enlite® Serter | MEDTRONIC MINIMED, INC. | 2014-09-24 |
| 00643169246096 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169277731 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169277724 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169277717 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169277700 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169277694 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169277687 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169246157 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169246140 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169246133 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169246126 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169246119 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169246102 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169246089 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169246072 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169246065 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169150294 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169150287 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169150270 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169150256 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169150249 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169150232 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169150225 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169150218 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169150195 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169150188 | MiniMed® 530G | MEDTRONIC MINIMED, INC. | 2014-09-23 |