PMA P130007S001

Device: ANIMAS VIBE SYSTEM
Applicant: Animas Corp.
PMA number: P130007
Supplement: S001
Product code: MDS
Decision date: 2015-04-14
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR IMPLEMENTATION OF DEXCOM¿S APPROVED SINGLE-PRINTED WIRING ASSEMBLY (PWA) CONFIGURATION TRANSMITTER INTO THE ANIMAS VIBE SYSTEM AS AN ALTERNATIVE TO THE CURRENT DUAL-PWA DESIGN.

Current openFDA PMA Record#

Device: ANIMAS VIBE SYSTEM
Applicant: Animas Corp.
PMA number: P130007
Supplement: S001
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2015-04-14
Decision code: APPR
Date received: 2015-01-23
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR IMPLEMENTATION OF DEXCOM¿S APPROVED SINGLE-PRINTED WIRING ASSEMBLY (PWA) CONFIGURATION TRANSMITTER INTO THE ANIMAS VIBE SYSTEM AS AN ALTERNATIVE TO THE CURRENT DUAL-PWA DESIGN.