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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.
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
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.