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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.
 
DeviceV.1 2A PROGRAMMER SOFTWARE
Generic NameProgrammer, pacemaker
ApplicantSt. Jude Medical, Inc.
15900 VALLEY VIEW Court
SYLMAR, CA 91342
PMA NumberP880006
Supplement NumberS033
Date Received08/11/2000
Decision Date09/07/2000
Withdrawal Date 05/07/2018
Product Codes DXY KRG 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND THE ALTERNATE STERILIZATION FACILITY AT STERIS ISOMEDIX, MINNEAPOLIS, MN.
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