PMA P130007S034
- Device
- Animas Vibe System
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S034
- Product code
- OYC
- Decision date
- 2018-03-12
- 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
- Changes to the manufacturing of the main printed circuit board assembly used in 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
- S034
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2018-03-12
- Decision code
- OK30
- Date received
- 2018-02-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the manufacturing of the main printed circuit board assembly used in the Animas Vibe Insulin pump. The Animas Vibe Insulin pump is a component of the Animas Vibe System.