PMA P130007S006

Device
ANIMAS VIBE SYSTEM
Applicant
Animas Corp.
PMA number
P130007
Supplement
S006
Product code
MDS
Decision date
2015-08-10
Classification
Sensor, Glucose, Invasive
Generic name
Sensor, glucose, invasive
Approval order statement
CHANGE TO THE MOLDING PRESS EQUIPMENT FOR SEVERAL ANIMAS VIBE PUMP COMPONENTS. THE ANIMAS VIBE PUMP IS A COMPONENT OF THE ANIMAS VIBE SYSTEM.

Current openFDA PMA Record#

Device
ANIMAS VIBE SYSTEM
Applicant
Animas Corp.
PMA number
P130007
Supplement
S006
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2015-08-10
Decision code
OK30
Date received
2015-07-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE TO THE MOLDING PRESS EQUIPMENT FOR SEVERAL ANIMAS VIBE PUMP COMPONENTS. THE ANIMAS VIBE PUMP IS A COMPONENT OF THE ANIMAS VIBE SYSTEM.