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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) MICRON ICD SYSTEM
ApplicantSULZER INTERMEDICS, INC.
PMA NumberP940008
Supplement NumberS008
Date Received11/26/1997
Decision Date12/29/1997
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a design change to the is-1 connector of the existing defibrillation/pacing leads.
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