PMA P980022S150

Device: PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP,
Applicant: Medtronic Minimed
PMA number: P980022
Supplement: S150
Product code: MDS
Decision date: 2014-03-13
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR CHANGES TO THE STACK ASSEMBLIES AND BATTERY TUBE ASSEMBLY TO COMPLY WITH ROHS (RESTRICTION OF HAZARDOUS SUBSTANCES) REQUIREMENTS. THESE CHANGES INCLUDE CHANGES TO FIVE COMPONENTS ON THE STACK ASSEMBLY, A CHANGE IN MATERIAL FOR THE BARE PRINTED CIRCUIT BOARDS (PCBS) OF THE STACK ASSEMBLY AND BATTERY TUBE ASSEMBLY, AND A CHANGE TO THE SOLDER MATERIAL (FROM TIN/LEAD TO TIN/SILVER/COPPER) USED ON THE PCBS.

Current openFDA PMA Record#

Device: PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP,
Applicant: Medtronic Minimed
PMA number: P980022
Supplement: S150
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2014-03-13
Decision code: APPR
Date received: 2013-12-23
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGES TO THE STACK ASSEMBLIES AND BATTERY TUBE ASSEMBLY TO COMPLY WITH ROHS (RESTRICTION OF HAZARDOUS SUBSTANCES) REQUIREMENTS. THESE CHANGES INCLUDE CHANGES TO FIVE COMPONENTS ON THE STACK ASSEMBLY, A CHANGE IN MATERIAL FOR THE BARE PRINTED CIRCUIT BOARDS (PCBS) OF THE STACK ASSEMBLY AND BATTERY TUBE ASSEMBLY, AND A CHANGE TO THE SOLDER MATERIAL (FROM TIN/LEAD TO TIN/SILVER/COPPER) USED ON THE PCBS.