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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.
 
DeviceTEMPO PULSE GENERATORS
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantSt. Jude Medical, Cardiac Rhythm Management Divisi
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP900070
Supplement NumberS021
Date Received09/29/1997
Decision Date10/16/1997
Withdrawal Date06/20/2007
Product Code DXY 
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 an alternate manufacturing facility located at Pacesetter, Inc., St. Jude Medical cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar CA.
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