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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMETA MV MODEL 1202 CARDIAC PACING SYSTEM
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantSt. Jude Medical, Inc.
15900 VALLEY VIEW Court
SYLMAR, CA 91342
PMA NumberP880038
Supplement NumberS015
Date Received08/27/1990
Decision Date09/19/1990
Withdrawal Date 06/20/2007
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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