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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.
 
DeviceV1. 2A PROGRAMMER SOFTWARE
Generic NameProgrammer, pacemaker
Regulation Number870.3700
ApplicantSt. Jude Medical, Inc.
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP830045
Supplement NumberS071
Date Received08/11/2000
Decision Date09/07/2000
Withdrawal Date06/20/2007
Product Code KRG 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ALTERNATE MANUFACTURING FICILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND ALTERNATE STERILIZATION FACILITY AT STERIS ISOMEDIX, MINNEAPOLIS MN.
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