PMA P130007S024
- Device
- Animas Vibe System
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S024
- Product code
- OYC
- Decision date
- 2017-04-21
- 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
- Implementation of a pump motor refurbishment process for the Animas Vibe Insulin Pump. The refurbishment activities will be conducted in the same building where current pump manufacturing occurs. The Animas Vibe Pump is a component of the Animas Vibe System with the Dexcom G4 PLATINUM Sensor and Transmitter.
Current openFDA PMA Record#
- Device
- Animas Vibe System
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S024
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2017-04-21
- Decision code
- OK30
- Date received
- 2017-03-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a pump motor refurbishment process for the Animas Vibe Insulin Pump. The refurbishment activities will be conducted in the same building where current pump manufacturing occurs. The Animas Vibe Pump is a component of the Animas Vibe System with the Dexcom G4 PLATINUM Sensor and Transmitter.