PMA P130007S019
- Device
- ANIMAS VIBE SYSTEM
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S019
- Product code
- OYC
- Decision date
- 2016-11-05
- Classification
- Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Approval order statement
- Approval for modifications to the attachment method that secures the disposable housing to the adhesive patch of the sensor pod of Dexcom’s G4 PLATINUM/G5 Mobile sensor component, which required modifications to the disposable housing, implementation of a semi-automated heat staking machine and a change to the inspection method. The sensor is a component of the Animas Vibe System.
Current openFDA PMA Record#
- Device
- ANIMAS VIBE SYSTEM
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S019
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2016-11-05
- Decision code
- APPR
- Date received
- 2016-07-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modifications to the attachment method that secures the disposable housing to the adhesive patch of the sensor pod of Dexcom’s G4 PLATINUM/G5 Mobile sensor component, which required modifications to the disposable housing, implementation of a semi-automated heat staking machine and a change to the inspection method. The sensor is a component of the Animas Vibe System.