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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NamePERCUTANEUS TRANSLUMINAL CORONARY ANGIOPLASTY CATH
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
PMA NumberP940009
Date Received02/16/1994
Decision Date09/29/1994
Reclassified Date 10/08/2010
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number 94M-0403
Notice Date 12/15/1994
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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