PMA P130007S008

Device: ANIMAL VIBE SYSTEM
Applicant: Animas Corp.
PMA number: P130007
Supplement: S008
Product code: MDS
Decision date: 2015-11-03
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR REPLACING THE FLASH MEMORY OF THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) USED IN THE ANIMAS VIBE INSULIN PUMP, A COMPONENT OF THE ANIMAS VIBE SYSTEM, AS WELL AS SUBSEQUENT SOFTWARE CHANGES.

Current openFDA PMA Record#

Device: ANIMAL VIBE SYSTEM
Applicant: Animas Corp.
PMA number: P130007
Supplement: S008
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2015-11-03
Decision code: APPR
Date received: 2015-08-20
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR REPLACING THE FLASH MEMORY OF THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) USED IN THE ANIMAS VIBE INSULIN PUMP, A COMPONENT OF THE ANIMAS VIBE SYSTEM, AS WELL AS SUBSEQUENT SOFTWARE CHANGES.