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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
PMA NumberP930012
Supplement NumberS010
Date Received05/08/1998
Decision Date06/15/1998
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) a change in trade names for the champion(tm) hp ptca catheters and champion(tm) hp ptca catheters with wrap(tm) sheathing system previously approved under pma supplements 5, 8, and 9, and 2) a reduction in the wall thickness of the 3. 5 mm and 4. 0 mm diameter balloons used in these designs. The devices, as modified, will be marketed under the trde names champion(tm) nc ptca catheter and wrap(tm) nc ptca catheter, and are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.