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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 NumberS009
Date Received01/08/1998
Decision Date02/23/1998
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of (1) quarter-size diameter balloons, including sizes of 2. 5 mm, 2. 75 mm, 3. 25 mm, 3. 75 mm, 4. 25 mm, and 4. 5 mm, and (2) a second radiopaque marker to all 20 mm long balloon catheters. The referenced devices are 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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