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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceTEMPO PULSE GENERATORS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
Applicant
ST. 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
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
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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