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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 NameMETA DDDR PACING SYSTEM
Classification Nameimplantable pacemaker pulse-generator
Generic Namecardiac pacing system
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP900070
Date Received11/29/1990
Decision Date01/30/1992
Withdrawal Date 06/20/2007
Product Code
DXY[ Registered Establishments with DXY ]
Docket Number 92m-0054
Notice Date 02/24/1992
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S009 S010 
S011 S012 S014 S015 S016 S017 S018 S019 S020 
S021 S022 S023 S024 S025 S026 S027 S028 S030 
S031 S032 S034 
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