PMA P130007S031
- Device
- Animas Vibe System
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S031
- Product code
- OYC
- Decision date
- 2017-10-24
- 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
- Supplier change for the manufacturing of a molded component of the key pad assembled into the Animas Vibe Insulin pump which is part of the Animas Vibe System. The Animas Vibe System consists of the Animas Vibe Insulin Pump paired with the Dexcom G4 PLATINUM Sensor and Transmitter.
Current openFDA PMA Record#
- Device
- Animas Vibe System
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S031
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2017-10-24
- Decision code
- OK30
- Date received
- 2017-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Supplier change for the manufacturing of a molded component of the key pad assembled into the Animas Vibe Insulin pump which is part of the Animas Vibe System. The Animas Vibe System consists of the Animas Vibe Insulin Pump paired with the Dexcom G4 PLATINUM Sensor and Transmitter.