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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.
 
DeviceCARELINK PROGRAMMER MODEL 2090 AND MODEL 9790/C PROGRAMMER
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP890003
Supplement NumberS260
Date Received09/13/2012
Decision Date09/05/2013
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR MULTIPLE DESIGN CHANGES, PACKAGING CHANGES, LABELING CHANGES, MANUFACTURING PROCESS CHANGES, AND A MANUFACTURING FACILITY TRANSFER TO TECHNICAL SERVICES FOR ELECTRONICS, INC., TSE TAIWAN MANUFACTURING FACILITY, WITH PACKAGING ACTIVITIES TO OCCUR AT THE TSE FACILITY IN JACKSON, MINNESOTA FOR THE 2090 EC/ECL ECG CABLE AND LEAD WIRES AND 148743 ECG PLUG.
Approval OrderApproval Order
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