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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMINIMED 530G INSULIN PUMP
Classification Nameartificial pancreas device system, threshold suspend
Generic Nameartificial pancreas device system, threshold suspend
Applicant
MEDTRONIC Inc.
18000 devonshire street
northridge, CA 91325-1219
PMA NumberP120010
Supplement NumberS008
Date Received12/23/2013
Decision Date03/13/2014
Product Code
OZO[ Registered Establishments with OZO ]
Advisory Committee Clinical Chemistry
Supplement Typereal-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.
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