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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 NamePOLY-SAFE(TM) A-TRACK(TM) PACING LEADS
Classification Nameimplantable pacemaker pulse-generator
Generic Namecardiac pacing system
Regulation Number870.3610
ApplicantCARDIAC CONTROL SYSTEMS, INC.
PMA NumberP890039
Supplement NumberS016
Date Received07/19/1996
Decision Date11/09/1998
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of biospan(r) (ms/0. 4 as a raw material for the polyurethane insulation for the above lead models.
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