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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Trade NameCHAMPION WRAP PTCA CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantPROGRESSIVE ANGIOPLASTY SYSTEMS, INC.
PMA NumberP930012
Supplement NumberS008
Date Received08/19/1997
Decision Date02/02/1998
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: 1) a line of champion(tm) hp ptca catheters packaged with the wrap(tm) sheathing system; 2) the additionof quarter-sized balloons to this line of catheters extending the balloon diameter limits from 3. 0-4. 0 mm to 2. 5-4. 5mm; and 3) a revised package insert which streamlines the instructions for use and compresses the previous package inserts for the 15 mm and 20 mm long balloons into one combined insert.
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