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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
one scimed place
maple grove, MN 55311
PMA NumberP880027
Supplement NumberS036
Date Received05/19/1995
Decision Date11/21/1995
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number N
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following:1)new labeling which complies to the fda's ptca package insert template 2)alternative packaging design and materials 3)a change in the material of the proximal to distal inner member transition sleeve 4)addition of 2. 25, 2. 75, 3. 25, and 3. 75 mm balloons with lengths of 20, 30, and 40mm 5)an increase in the inner and outer diameters of the proximal shaft and distal stem of the catheters having 20 mm balloons 6)an alternative design configuration which places the shaft to stem bond distal to the inner member hypotube transition, not proximal.