PMA P130007S022
- Device
- ANIMAS VIBE SYSTEM
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S022
- 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 a change to the Animas Vibe System labeling to specify compatibility with OneTouch infusion sets.
Current openFDA PMA Record#
- Device
- ANIMAS VIBE SYSTEM
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S022
- 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
- 2016-09-19
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a change to the Animas Vibe System labeling to specify compatibility with OneTouch infusion sets.