PMA P130007S018
- Device
- ANIMAS VIBE SYSTEM
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S018
- Product code
- OYC
- Decision date
- 2016-08-24
- 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
- Modify the cartridge leak test process for the Animas Vibe Insulin Pump, from a manual leak test to an automated leak test. 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
- S018
- Product code
- OYC
- Generic name
- Pump, infusion, insulin, to be used with invasive glucose sensor
- Decision date
- 2016-08-24
- Decision code
- OK30
- Date received
- 2016-07-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the cartridge leak test process for the Animas Vibe Insulin Pump, from a manual leak test to an automated leak test. The Animas Vibe Insulin Pump is a component of the Animas Vibe System.