|
Device | MINIMED 530G INSULIN PUMP |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC Inc. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P120010 |
Supplement Number | S008 |
Date Received | 12/23/2013 |
Decision Date | 03/13/2014 |
Product Code |
OZO |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |