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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 JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
PMA NumberP860019
Supplement NumberS135
Date Received11/24/1997
Decision Date12/22/1997
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: 1)the addition of balloon diameters of 4. 5 mm and 5. 0 mm to the currently approved 15 mm length of the nc rebel(tm) ptca catheter, and 2) an additional balloon length of 30 mm with balloon diameters of 2. 5 mm up to 4. 0 mm in 1/4 mm increments for the nc rebel(tm) ptca catheter.
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