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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Trade NameRELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator and programmer
Regulation Number870.3610
PMA NumberP910020
Date Received04/11/1991
Decision Date06/15/1992
Withdrawal Date 07/20/2012
Product Code
DXY[ Registered Establishments with DXY ]
Docket Number n2M-0263
Notice Date 08/07/1992
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S023 S024 S025 S026 S027