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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 COYOTE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Name catheter
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
PMA NumberP860019
Supplement NumberS151
Date Received12/14/1998
Decision Date01/11/1999
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the reduction in the rated burst pressure from 16 to 14 atm for all available lengths (20, 30, and 40mm) of the 2. 0mm and 2. 5mm diameter balloon sizes of the coyote(tm) ptca catheter.
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