PMA P130007S015
- Device
- ANIMAS VIBE SYSTEM
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S015
- Product code
- OYC
- Decision date
- 2016-06-01
- 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 transfer the complaint return and investigation operations for the Dexcom G4 Platinum Sensors from the Dexcom facility in San Diego, California, to the Animas facility in West Chester, Pennsylvania. The Dexcom G4 Platinum Sensors are a component of the Animas Vibe System.
Current openFDA PMA Record#
- Device
- ANIMAS VIBE SYSTEM
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S015
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2016-06-01
- Decision code
- OK30
- Date received
- 2016-05-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to transfer the complaint return and investigation operations for the Dexcom G4 Platinum Sensors from the Dexcom facility in San Diego, California, to the Animas facility in West Chester, Pennsylvania. The Dexcom G4 Platinum Sensors are a component of the Animas Vibe System.