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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 NameDIVA PLATFORM,DERMA PLATFORM
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator programming software
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
PMA NumberP990001
Supplement NumberS013
Date Received12/03/2002
Decision Date02/21/2003
Product Code
DXY[ Registered Establishments with DXY ]
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 eoc manufacturing operations in kerkrade, the netherlands to eoc, medtronic b. V. , heerlen, the netherlands.
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