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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSCIMED PTCA CATHETERS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP860019
Supplement NumberS176
Date Received08/06/2001
Decision Date09/07/2001
Reclassified Date 10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ALTERNATE FACILITIES FOR PACKAGING AND LABELING LOCATED AT BOSTON SCIENTIFIC CORPORATION, QUINCY, MASSACHUSETTS AND BONSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER, BEEK, THE NETHERLANDS.
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