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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Trade NamePAS CHAMPION HP PTCA CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantPROGRESSIVE ANGIOPLASTY SYSTEMS, INC.
PMA NumberP930012
Supplement NumberS005
Date Received08/01/1996
Decision Date01/29/1997
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the pas champion(tm) hp (high pressure) ptca catheter with the following balloon sizes:3. 0 mm, 3. 5 mm, 4. 0 mm diameters with 15 mm and 20 mm lengths. This device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
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