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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 NumberS008
Date Received08/19/1997
Decision Date02/02/1998
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
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 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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