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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.
 
DeviceMEDA-MV PACING SYSTEM
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantSt. Jude Medical, Inc.
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP880038
Supplement NumberS030
Date Received02/02/1995
Decision Date08/14/1995
Withdrawal Date06/20/2007
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR TELEMETRY COIL IMPROVEMENT, SCAMP PROCESSOR MICROCODE MODIFICATION, & SUBSTITUTION OF DOW SILASTIC MEDICAL ADHESIVE TYPE A FOR THE LOCTITE USED IN THE ATTACHMENT OF OSCILLATOR CRYSTALS TO CERAMICS SUBSTRATES
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