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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-MV,PACING SYSTEM
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP880038
Date Received05/17/1988
Decision Date04/07/1989
Withdrawal Date 06/20/2007
Product Code
DXY[ Registered Establishments with DXY ]
Docket Number 89M-0137
Notice Date 05/17/1989
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S008 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 
S021 S022 S023 S024 S025 S028 S029 S030 S031 
S033 S034 S035 S037 
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