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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 NameMODEL 7230 MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS031
Date Received12/20/2002
Decision Date03/06/2003
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a move of the european operations center from kerkrade, the netherlands to medtronic b. V. , heerleen, the netherlands.
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