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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.
 
DeviceEXTENSION TO THE PAS LACROSSE 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 NumberS002
Date Received10/04/1995
Decision Date04/16/1996
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  
ADDITION OF 1.5MM DIAMETER, 20 MM LENGTH BALLOON; ADDITION OF 2.5MM, 3.0MM, AND 4.0MM BALLOONS, ALL WITH 30MM LENGTH; CHANGE IN RATED BURST OF THE 2.0MM AND 2.5MM BALLOONS WITH 20MM LENGTH
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