PMA P130007S002

Device: ANIMAS VIBE SYSTEM
Applicant: Animas Corp.
PMA number: P130007
Supplement: S002
Product code: MDS
Decision date: 2015-06-22
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR SUBSTITUTION OF 4 COMPONENTS (MEMORY, TRANSISTOR, MICRO-PROCESSING UNIT, CONNECTOR) ON THE PRINTED CIRCUIT BOARD (PCB) OF THE APPROVED ANIMAS VIBE INSULIN PUMP. ONE OF THE REPLACEMENT COMPONENTS (MICRO-PROCESSING UNIT) REQUIRES A MODIFICATION TO THE PCB LAYOUT.

Current openFDA PMA Record#

Device: ANIMAS VIBE SYSTEM
Applicant: Animas Corp.
PMA number: P130007
Supplement: S002
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2015-06-22
Decision code: APPR
Date received: 2015-03-26
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR SUBSTITUTION OF 4 COMPONENTS (MEMORY, TRANSISTOR, MICRO-PROCESSING UNIT, CONNECTOR) ON THE PRINTED CIRCUIT BOARD (PCB) OF THE APPROVED ANIMAS VIBE INSULIN PUMP. ONE OF THE REPLACEMENT COMPONENTS (MICRO-PROCESSING UNIT) REQUIRES A MODIFICATION TO THE PCB LAYOUT.