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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSTAT-PACE II
Generic NameSYSTEM, ESOPHAGEAL PACING
ApplicantCardiocommand, Inc.
4920 W. Cypress St.
Suite 110
Tampa, FL 33607
PMA NumberP840002
Date Received11/19/1984
Decision Date04/30/1986
Product Code LPA 
Docket Number 86M-0237
Notice Date 07/01/1986
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Supplements:  S001 S007 S008 S009 S010 S011 S012 S013 
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