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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.
 
DeviceMODEL 9602 PROGRAMMER
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantSt. Jude Medical, Inc.
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP820018
Supplement NumberS072
Date Received04/24/1997
Decision Date04/29/1997
Withdrawal Date06/20/2007
Product Code LWP 
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  
ALTERNATE MANUFACTURING SITE FOR THE MODEL 9602 PROGRAMMER. THE SITE IS LOCATED AT PACESETTER, INC., 15900 VALLEY VIEW CT., SYLMAR, CA.
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