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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.
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
PMA NumberP890003
Supplement NumberS050
Date Received05/05/1997
Decision Date06/03/1998
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for new pacing lead models. The devices, as modified, will be marketed under the trade names: medtronic models 5038-58, 5038-65, 5038-52, 5038s-58, and 5038l-65 capsure vdd-2 and vitatron models imw 14q/15q/16q/17q/18q brilliant s+ vdd pacing leads and are indicated for bipolar sensing in the atrium and bipolar sensing and pacing in the ventricle when used with current medtronic(r) vdd pacemakers.