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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSCIMED PTCA DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca dilatation catheter
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
PMA NumberP860019
Date Received05/23/1986
Decision Date11/28/1986
Reclassified Date 10/08/2010
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number 86M-0496
Notice Date 01/16/1987
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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