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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 PTCA DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nametransluminal coronary angioplasty catheters, percu
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
PMA NumberP860019
Supplement NumberS008
Date Received03/08/1988
Decision Date05/18/1988
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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