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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMETA DDDR PACING SYSTEM
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP900070
Date Received11/29/1990
Decision Date01/30/1992
Withdrawal Date 06/20/2007
Product Code DXY 
Docket Number 92m-0054
Notice Date 02/24/1992
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S004 S005 S006 S007 S009 S010 S011 S012 
S014 S015 S016 S017 S025 S026 S030 S031 S023 S024 S018 S019 
S020 S021 S022 S027 S028 S032 S034 
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