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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) SURPASS(TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY
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 NumberS111
Date Received04/16/1996
Decision Date07/01/1996
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 the scimed surpass percutaneous transluminal coronary angioplasty (ptca) perfusion catheter. The device, as modified, will be marketed for the balloon dilatation of the stenotic portio of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
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