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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 St. NE
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
Predetermined Change Control Plan AuthorizedNo
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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