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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 NameVENTAK P MODELS 1600&1610 & SOFTWARE MODULE 2830
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP890061
Supplement NumberS001
Date Received05/07/1991
Decision Date02/10/1992
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
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