PMA P130007S003

Device: ANIMAS VIBE SYSTEM
Applicant: Animas Corp.
PMA number: P130007
Supplement: S003
Product code: MDS
Decision date: 2015-10-30
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR A CHANGE TO THE MANUFACTURING LOCATION AND PROCESS FOR SPRAY PAINT COATING OF THE ANIMAS VIBE INSULIN PUMP OUTER PLASTIC BASE AND COVER. 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: S003
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2015-10-30
Decision code: APPR
Date received: 2015-04-10
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE TO THE MANUFACTURING LOCATION AND PROCESS FOR SPRAY PAINT COATING OF THE ANIMAS VIBE INSULIN PUMP OUTER PLASTIC BASE AND COVER. THE ANIMAS VIBE INSULIN PUMP IS A COMPONENT OF THE ANIMAS VIBE SYSTEM.