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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namepercutaneous transluminal coronary angioplasty catheter
Regulation Number870.5100
ApplicantCOOK, INC.
PMA NumberP990008
Date Received02/11/1999
Decision Date09/27/1999
Withdrawal Date 09/28/2009
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number 99M-4276
Notice Date 10/18/1999
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order