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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.
 
DeviceSCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
Applicant
SCIMED LIFE SYSTEMS, INC.
one scimed place
maple grove, MN 55311-1566
PMA NumberP860019
Supplement NumberS126
Date Received07/16/1997
Decision Date08/12/1997
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional balloon sizes (22 mm and 30 mm lengths with balloon sizes of 2. 5 mm up to 4. 0 mm in 1/4 sizes) for the scimed(r) quantum ranger(tm) ptca catheter.
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