PMA P130007
- Device
- Animas Vibe System
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S036
- Product code
- OYC
- Decision date
- 2018-07-11
- 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 the incoming acceptance activities for the insulin cartridge used with 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
- S036
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2018-07-11
- Decision code
- OK30
- Date received
- 2018-06-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of the incoming acceptance activities for the insulin cartridge used with the Animas Vibe Insulin Pump. The Animas Vibe Insulin pump is a component of the Animas Vibe System.