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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCHAMPION WRAP PTCA CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantProgressive Angioplasty Systems, Inc.
1350 Willow Rd.
Suite 201
Menlo Park, CA 94025
PMA NumberP930012
Supplement NumberS010
Date Received05/08/1998
Decision Date06/15/1998
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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