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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NamePROGRESSIVE ANGTIOPLASTY SYSTEMS (PAS) CHAMPION PTCA CORONARY DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantPROGRESSIVE ANGIOPLASTY SYSTEMS, INC.
PMA NumberP930012
Supplement NumberS003
Date Received11/13/1995
Decision Date05/22/1996
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 ptca catheters.
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