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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) RANGER(TM) PERCUTANEOUS 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 NumberS122
Date Received05/09/1997
Decision Date06/05/1997
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional statements to sections f4 and 4g of the instructions for use advising the user to depress the lock button before advancing or withdrawing the contrast displacement rod (cdr).
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