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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.
 
Trade NameSCIMED(R) 10MM & 20MM NC BANDIT(TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namescimed(r) ace(tm) 1cm tip ptca catheter
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
PMA NumberP860019
Supplement NumberS110
Date Received01/19/1996
Decision Date02/26/1996
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 
Approval for:1)10 and 20 mm balloon lengths; 2) 2. 0 and 2. 25 diameter balloons in the 20 mm length; and 3) the use of an epoxy adhesive forthe manifold bond.
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