FDA.reportPublic FDA data

PMA P120010S125

Device
MiniMed 530G System
Applicant
Medtronic, Inc.
PMA number
P120010
Supplement
S125
Product code
OZO
Decision date
2018-11-30
Classification
Automated Insulin Dosing , Threshold Suspend
Generic name
Automated insulin dosing , threshold suspend
Approval order statement
Use of the barcode labels for the material identification process for the Enlite Sensor components/assembly at Medtronic Puerto Rico Operations Company (MPROC) for the following systems: MiniMed 530G System, MiniMed 630G System with SmartGuard, iPro2 CGM System with Enlite Sensor, and Paradigm Real-Time Revel System.

Current openFDA PMA Record#

Device
MiniMed 530G System
Applicant
Medtronic, Inc.
PMA number
P120010
Supplement
S125
Product code
OZO
Generic name
Automated insulin dosing , threshold suspend
Decision date
2018-11-30
Decision code
OK30
Date received
2018-11-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use of the barcode labels for the material identification process for the Enlite Sensor components/assembly at Medtronic Puerto Rico Operations Company (MPROC) for the following systems: MiniMed 530G System, MiniMed 630G System with SmartGuard, iPro2 CGM System with Enlite Sensor, and Paradigm Real-Time Revel System.