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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 NamePOLYSAFE(TM) A-TRACK(TM) MODEL AT-332 ENDOCARDIAL
Classification Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
ApplicantCARDIAC CONTROL SYSTEMS, INC.
PMA NumberP890039
Supplement NumberS001
Date Received12/17/1990
Decision Date01/21/1992
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
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