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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.
 
DeviceLACROSSE PTCA CATHETER/CHAMPION PTCA CATHETER PRODUCT LINE
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 NumberS012
Date Received07/24/1998
Decision Date08/25/1998
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change in labeling for the LaCrosse(TM) PTCA and Champion(TM) PTCA Catheter Product Lines. Specifically, the change included a reduction in the labeled rated burst pressures for the 2.5mmx20mm, 3.0mmx30mm, and 3.5mmx30mm LaCrosse(TM) PTCA Catheters and the 2.0mmx20mm Champion(TM) PTCA Catheter.
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