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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameOPUS RM 4534 AND CHORUS RM 7034 PACEMAKERS
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator, pacemaker
Regulation Number870.3610
ApplicantELA MEDICAL, INC.
PMA NumberP950029
Supplement NumberS003
Date Received09/10/1998
Decision Date11/18/1998
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a sterilization site located at griffith microscience s. A. , 8 rue parmentier, 60290 rantigny, france.
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