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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 Namescimed(r) ace(tm) 1cm tip ptca catheter
Regulation Number870.5100
PMA NumberP860019
Supplement NumberS100
Date Received06/12/1995
Decision Date08/17/1995
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
New ptca catheter based on 4 modifications to scimed express plus ii ptca catheter:addtion of leap balloon material,thinner balloon marker band,orange manifold,ii will be dropped from name trade name:scimed leap express plus ptca catheter.