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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 NumberS004
Date Received10/22/1996
Decision Date02/28/1997
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new implantable cardioverter defibrillator (icd) system. The device, as modified, will be marketed under the trade name res-q(tm) micron model 101-09 and mdoel 101-05.
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