PMA P130007S010

Device: ANIMAS VIBE SYSTEM
Applicant: Animas Corp.
PMA number: P130007
Supplement: S010
Product code: MDS
Decision date: 2016-03-02
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Change in the current Animas Vibe Insulin Pump final QC/kitting process required to implement process improvements to eliminate an unnecessary parts reconciliation process, eliminate process redundancy, and to improve overall manufacturing process efficiency. 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: S010
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2016-03-02
Decision code: OK30
Date received: 2016-02-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in the current Animas Vibe Insulin Pump final QC/kitting process required to implement process improvements to eliminate an unnecessary parts reconciliation process, eliminate process redundancy, and to improve overall manufacturing process efficiency. The Animas Vibe Insulin Pump is a component of the Animas Vibe System.