PMA P130007S023
- Device
- Animas Vibe System
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S023
- Product code
- OYC
- Decision date
- 2017-04-20
- 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
- Relocation of a contract manufacturing facility for the injection molding process for the Drive Housing and Dual Vent Housing components which are assembled into the Animas Vibe Insulin pump. The Animas Vibe Insulin pump is a component of the Animas Vibe System.
Current openFDA PMA Record#
- Device
- Animas Vibe System
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S023
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2017-04-20
- Decision code
- OK30
- Date received
- 2017-03-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of a contract manufacturing facility for the injection molding process for the Drive Housing and Dual Vent Housing components which are assembled into the Animas Vibe Insulin pump. The Animas Vibe Insulin pump is a component of the Animas Vibe System.