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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 NameRES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS
ApplicantINTERMEDICS, INC.
PMA NumberP940008
Supplement NumberS003
Date Received02/20/1996
Decision Date08/22/1996
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to consider the information provided in this supplement as an alternative response to the conditions of approval set forth in the fda letter dated november 7, 1995. The condition required that remaining minor software anomalies be corrected.
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