PMA P130007S014
- Device
- ANIMAS VIBE SYSTEM
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S014
- Product code
- OYC
- Decision date
- 2016-07-06
- 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
- Approval for a change to the solder composition for three subassemblies used in the Animas Vibe pump as required for RoHS compliance. The Animas Vibe pump is a component of the Animas Vibe System.
Current openFDA PMA Record#
- Device
- ANIMAS VIBE SYSTEM
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S014
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2016-07-06
- Decision code
- APPR
- Date received
- 2016-04-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to the solder composition for three subassemblies used in the Animas Vibe pump as required for RoHS compliance. The Animas Vibe pump is a component of the Animas Vibe System.