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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 NameMODEL 0010 BIPOLAR ENDOCARDIAL LEAD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameautomatic implantable cardioverter defibrillator
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP830060
Supplement NumberS039
Date Received05/01/1995
Decision Date08/28/1995
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design changes to the model 0010 lead and to use a "tray-in-tray" packaging system fro the lead.
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