Product code OYC
- Device name
- Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
- 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
- The insulin pump is intended to be used as a component of an invasive glucose device. The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P140015S029 | t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System | Tandem Diabetes Care, Inc. | 2019-12-19 |
| P140015S028 | t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System | Tandem Diabetes Care, Inc. | 2019-03-01 |
| P140015S027 | t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM | Tandem Diabetes Care, Inc. | 2018-10-26 |
| P140015S026 | t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM | Tandem Diabetes Care, Inc. | 2018-10-11 |
| P130007S036 | Animas Vibe System | Animas Corp. | 2018-07-11 |
| P140015S025 | t:slim X2 Insulin Pump with DexcomG5 Mobile CGM System | Tandem Diabetes Care, Inc. | 2018-05-02 |
| P130007S035 | Animas Vibe System | Animas Corp. | 2018-04-18 |
| P140015S024 | t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM (t:slim G4 system); t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM | Tandem Diabetes Care, Inc. | 2018-04-17 |
| P130007S034 | Animas Vibe System | Animas Corp. | 2018-03-12 |
| P130007S033 | Animas Vibe System | Animas Corp. | 2018-03-01 |
| P140015S023 | t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM | Tandem Diabetes Care, Inc. | 2018-02-14 |
| P140015S021 | t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM | Tandem Diabetes Care, Inc. | 2017-12-21 |
| P130007S027 | Animas Vibe System | Animas Corp. | 2017-10-27 |
| P130007S031 | Animas Vibe System | Animas Corp. | 2017-10-24 |
| P140015S020 | t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM | Tandem Diabetes Care, Inc. | 2017-08-25 |
| P130007S029 | Animas Vibe System | Animas Corp. | 2017-08-17 |
| P140015S022 | G4 Insulin Pump with Dexcom G4 Platinum CGM System | Tandem Diabetes Care, Inc. | 2017-06-15 |
| P130007S026 | Animas, Vibe System | Animas Corp. | 2017-06-09 |
| P130007S024 | Animas Vibe System | Animas Corp. | 2017-04-21 |
| P130007S023 | Animas Vibe System | Animas Corp. | 2017-04-20 |
| P140015S017 | T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM | Tandem Diabetes Care, Inc. | 2017-03-20 |
| P140015S016 | T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM | Tandem Diabetes Care, Inc. | 2017-03-06 |
| P140015S019 | T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM | Tandem Diabetes Care, Inc. | 2017-02-08 |
| P140015S018 | T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM | Tandem Diabetes Care, Inc. | 2017-01-18 |
| P130007S016 | OneTouch Vibe™ Plus System | Animas Corp. | 2016-12-16 |
| P130007S022 | ANIMAS VIBE SYSTEM | Animas Corp. | 2016-11-05 |
| P130007S019 | ANIMAS VIBE SYSTEM | Animas Corp. | 2016-11-05 |
| P140015S012 | T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM | Tandem Diabetes Care, Inc. | 2016-10-04 |
| P140015S011 | T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM | Tandem Diabetes Care, Inc. | 2016-10-04 |
| P140015S015 | T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM | Tandem Diabetes Care, Inc. | 2016-09-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000423131 | Paradigm® REAL-Time Revel™ | MEDTRONIC MINIMED, INC. | 2020-11-15 |
| 00763000423124 | Paradigm® REAL-Time | MEDTRONIC MINIMED, INC. | 2020-11-15 |
| 00763000161088 | PARADIGM® REAL-time | MEDTRONIC MINIMED, INC. | 2018-09-30 |
| 00763000161132 | Paradigm® REAL-Time Revel™ | MEDTRONIC MINIMED, INC. | 2018-09-28 |
| 00763000164300 | MiniLink® REAL-Time | MEDTRONIC MINIMED, INC. | 2018-07-07 |
| 10840406103106 | Animas Vibe | ANIMAS CORPORATION | 2018-01-15 |
| 00643169933170 | Paradigm® REAL-Time Revel™ | MEDTRONIC MINIMED, INC. | 2017-11-30 |
| 00643169933125 | PARADIGM® REAL-time | MEDTRONIC MINIMED, INC. | 2017-11-30 |
| 10840406103823 | Animas Vibe | ANIMAS CORPORATION | 2017-09-21 |
| 20613994598404 | SOF-SENSOR ® | MEDTRONIC MINIMED, INC. | 2016-10-10 |
| 00643169283183 | Medtronic Guardian™ Link | MEDTRONIC MINIMED, INC. | 2016-09-23 |
| 00643169462724 | Enlite™ Serter | MEDTRONIC MINIMED, INC. | 2016-08-14 |
| 00613994933072 | Enlite™ Serter | MEDTRONIC MINIMED, INC. | 2016-08-14 |
| 10840406100570 | Animas Vibe | ANIMAS CORPORATION | 2016-03-14 |
| 10840406100334 | Animas Vibe | ANIMAS CORPORATION | 2015-11-16 |
| 10840406100136 | Animas 2.0 mL Cartridge | ANIMAS CORPORATION | 2015-09-17 |
| 10840406100013 | Animas Vibe | ANIMAS CORPORATION | 2015-09-17 |
| 00643169246478 | Enlite® Serter | MEDTRONIC MINIMED, INC. | 2014-09-24 |
| 00613994287212 | PARADIGM® REAL-time | MEDTRONIC MINIMED, INC. | 2014-09-24 |
| 00613994224484 | PARADIGM® REAL-time | MEDTRONIC MINIMED, INC. | 2014-09-24 |
| 00613994141651 | PARADIGM® REAL-time | MEDTRONIC MINIMED, INC. | 2014-09-24 |
| 00613994906052 | mySentry™ | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169151369 | Paradigm® REAL-Time Revel™ | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00613994904485 | Paradigm® REAL-Time Revel™ | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00613994748898 | Paradigm® REAL-Time Revel™ | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169478602 | Paradigm® REAL-Time Revel™ | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00643169513914 | Paradigm® REAL-Time Revel™ | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00613994409553 | PARADIGM® REAL-time | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00613994375407 | PARADIGM® REAL-time | MEDTRONIC MINIMED, INC. | 2014-09-23 |
| 00613994343604 | CGMS® iPro™ | MEDTRONIC MINIMED, INC. | 2014-09-23 |