PMA P130007S007

Device: ANIMAS VIBE SYSTEM
Applicant: Animas Corp.
PMA number: P130007
Supplement: S007
Product code: MDS
Decision date: 2015-08-18
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: CHANGE TO THE CURRENT BASE ASSEMBLY PROCESS USED FOR THE MANUFACTURE OF THEPUMP BASE OF THE ANIMAS VIBE SYSTEM TO IMPROVE OVERALL MANUFACTURING PROCESS EFFICIENCY. THE PROPOSED CHANGES INCLUDE REMOVAL OF REDUNDANT TEST STEPS, SEPARATION OF COMPLEX ASSEMBLYOPERATIONS INTO SEVERAL DISCRETE STEPS, AND THE ADDITION OF AN IDENTICAL ASSEMBLY STATION.

Current openFDA PMA Record#

Device: ANIMAS VIBE SYSTEM
Applicant: Animas Corp.
PMA number: P130007
Supplement: S007
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2015-08-18
Decision code: OK30
Date received: 2015-07-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE CURRENT BASE ASSEMBLY PROCESS USED FOR THE MANUFACTURE OF THEPUMP BASE OF THE ANIMAS VIBE SYSTEM TO IMPROVE OVERALL MANUFACTURING PROCESS EFFICIENCY. THE PROPOSED CHANGES INCLUDE REMOVAL OF REDUNDANT TEST STEPS, SEPARATION OF COMPLEX ASSEMBLYOPERATIONS INTO SEVERAL DISCRETE STEPS, AND THE ADDITION OF AN IDENTICAL ASSEMBLY STATION.