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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 NumberS009
Date Received12/24/1997
Decision Date03/17/1998
Advisory Committee Anesthesiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for new models of res-q(tm) micron icd (models 101-10 and 101-10a) and modifications to the existing res-q(tm) micron icd models 101-05, and 101-09.
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