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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 NameSELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
Classification Namepermanent pacemaker electrode
Generic Nametransvenous unipolar/bipolar pacing lead
Regulation Number870.3680
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP950001
Supplement NumberS002
Date Received04/03/1997
Decision Date09/19/1997
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change in location pilot
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site lcoated at cardiac pacemakers, inc. , del caribe, road 698 lot no. 12, dorado, pr 00646.
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