PMA P120010S003

Device: MINILINK REAL-TIME TRANSMITTER
Applicant: Medtronic, Inc.
PMA number: P120010
Supplement: S003
Product code: OZO
Decision date: 2014-09-25
Classification: Automated Insulin Dosing , Threshold Suspend
Generic name: Automated insulin dosing , threshold suspend
Approval order statement: APPROVAL FOR A CHANGE TO THE SUPPLIER AND MATERIAL OF THE BATTERY ANODE FOR THE MINILINK REAL-TIME TRANSMITTER (MODEL: MMT-7703), THE IPRO2 RECORDER (MODEL: MMT-7741) AND THE MINILINK REAL-TIME TRANSMITTER (MODEL: MMT-7703), WHICHARE COMPONENTS OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, MINILINK REAL-TIME, IPRO2 PROFESSIONAL CGM AND MINIMED 530G SYSTEMS.

Current openFDA PMA Record#

Device: MINILINK REAL-TIME TRANSMITTER
Applicant: Medtronic, Inc.
PMA number: P120010
Supplement: S003
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
Decision date: 2014-09-25
Decision code: APPR
Date received: 2013-11-07
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 SUPPLIER AND MATERIAL OF THE BATTERY ANODE FOR THE MINILINK REAL-TIME TRANSMITTER (MODEL: MMT-7703), THE IPRO2 RECORDER (MODEL: MMT-7741) AND THE MINILINK REAL-TIME TRANSMITTER (MODEL: MMT-7703), WHICHARE COMPONENTS OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, MINILINK REAL-TIME, IPRO2 PROFESSIONAL CGM AND MINIMED 530G SYSTEMS.