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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameEXTENSION TO THE PAS LACROSSE PTCA CATHETER PRODUCT LINE
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantPROGRESSIVE ANGIOPLASTY SYSTEMS, INC.
PMA NumberP930012
Supplement NumberS002
Date Received10/04/1995
Decision Date04/16/1996
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
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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