PMA P120010S064

Device: MINIMED 530G SYSTEM, MINILINK REAL-TIME SYSTEM
Applicant: Medtronic, Inc.
PMA number: P120010
Supplement: S064
Product code: OZO
Decision date: 2016-01-21
Classification: Automated Insulin Dosing , Threshold Suspend
Generic name: Automated insulin dosing , threshold suspend
Approval order statement: APPROVAL FOR THE ADDITION OF A NEW LEAK TESTER TO THE MANUFACTURING PROCESS OF THE PARADIGM® REAL-TIME FAMILY OF INSULIN PUMPS AND THE MINIMED 530G INSULIN PUMP AT MEDTRONIC PUERTO RICO OPERATIONS CO. (MPROC). THE PARADIGM® REAL-TIME FAMILY OF INSULIN PUMPS AND THE MINIMED 530G INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL-TIME/REAL-TIME REVEL SYSTEMS AND THE MINIMED 530G SYSTEM, RESPECTIVELY.

Current openFDA PMA Record#

Device: MINIMED 530G SYSTEM, MINILINK REAL-TIME SYSTEM
Applicant: Medtronic, Inc.
PMA number: P120010
Supplement: S064
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
Decision date: 2016-01-21
Decision code: APPR
Date received: 2015-03-10
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE ADDITION OF A NEW LEAK TESTER TO THE MANUFACTURING PROCESS OF THE PARADIGM® REAL-TIME FAMILY OF INSULIN PUMPS AND THE MINIMED 530G INSULIN PUMP AT MEDTRONIC PUERTO RICO OPERATIONS CO. (MPROC). THE PARADIGM® REAL-TIME FAMILY OF INSULIN PUMPS AND THE MINIMED 530G INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL-TIME/REAL-TIME REVEL SYSTEMS AND THE MINIMED 530G SYSTEM, RESPECTIVELY.