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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
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
PMA NumberP860019
Supplement NumberS124
Date Received06/30/1997
Decision Date07/15/1997
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change from 1 to 2 marker bands for the 20 mm balloon length ranger(tm) ptca catheter and for a change that makes all ranger(tm) ptca catheter (20, 30, and 40 mm balloon lengths) marker band locations proximal and distal.
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