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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameMAGELLAN-C PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY(PTCA) CATHETERS MODEL C22020,C22520,C23020,& C23520
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantGLOBAL THERAPEUTICS, INC.
PMA NumberP960014
Date Received05/10/1996
Decision Date10/05/1998
Withdrawal Date 03/27/2009
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number 98M-0897
Notice Date 11/18/1998
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Indicated for balloon dilatation of the stenotic portion of a coronary or bypass graft stenosis for the purpose of improving myocardial perfusion.
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