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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.
ApplicantCOOK, INC.
P.O. BOX 489
PMA NumberP910030
Date Received06/06/1991
Decision Date02/08/1993
Withdrawal Date 06/30/2009
Product Code MAF 
Docket Number 93M-0212
Notice Date 07/22/1993
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S005 S008 S009