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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceCOOK MBC PTCA BALLOON DILATATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantCOOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON, IN 47402
PMA NumberP990008
Date Received02/11/1999
Decision Date09/27/1999
Withdrawal Date 09/28/2009
Product Code LOX 
Docket Number 99M-4276
Notice Date 10/18/1999
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Cook(R) MBC PTCA Balloon Dilatation Catheter (sizes noted in the enclosure). This device is indicated for balloon dilatation of hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for th epurpose of improving myocardial perfusion.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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