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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.
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP910077
Supplement NumberS012
Date Received09/12/1995
Decision Date04/29/1996
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the ventak mini hc (models 1742, 1743, and 1640) which is an active can version of your commercially available ventak mini aicd system and the ventak mini ii hc aicd system (models 1652, 1662, 1752, 1762, 1753, and 1763) which is a down-sized version of the ventak mini hc aicd system. The mini ii hc maximum energy levels are 25 and 27 jewels where the mini hc maximum energy level is 29 jewels.