PMA P130007S013
- Device
- ANIMAS VIBE SYSTEM
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S013
- Product code
- OYC
- Decision date
- 2016-05-12
- 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
- Change to implement a new fixture, new set-up configuration, and a control software modification for the purpose of increasing throughput for one of the incoming inspection processes used for lot acceptance of the insulin cartridges of 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
- S013
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2016-05-12
- Decision code
- OK30
- Date received
- 2016-04-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to implement a new fixture, new set-up configuration, and a control software modification for the purpose of increasing throughput for one of the incoming inspection processes used for lot acceptance of the insulin cartridges of the Animas Vibe Insulin Pump. The Animas Vibe Insulin Pump is a component of the Animas Vibe System.