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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.
 
DeviceSYNCHRONY,SYNCHRONY II & III SOLUS, SOLUS II & TRIOLOGY PACEMAKERS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
Applicant
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
PMA NumberP880086
Supplement NumberS035
Date Received03/12/1996
Decision Date10/09/1996
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
MODIFICATION TO THE LABELING TO INCLUDE A "CELLULAR TESTED" LOGO TO THE SHELF PACKAGE OF THE FOLLOWING PACEMAKER MODELS: PHOENIX 2 (2005/2008/2009), PARAGON (2010/2011/2012), PARAGON II (2016), SYNCHRONY (2020), SYNCHRONY II (2022/2023), SYNCHRONY III (2028/2029), SOLUS (2002/2003), SOLUS II (2006/2007), TRILOGY (2350/2308/2250) AND REVISION OF THE PATIENT MANUAL TO INCLUDE THE LOGO AND LANGUAGE INFORMING THE PATIENT THAT NO SPECIAL CELL PHONE PRECAUTIONS NEED TO BE TAKEN BY PATIENTS RECEIVING THESE MODELS
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