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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 CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantSCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP860019
Supplement NumberS161
Date Received04/06/2000
Decision Date04/26/2000
Reclassified Date 10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Change in manufacturing method from an acid-etch to a centerless grinding process for the distal taper in the corewire subassembly in fixed wire models of PTCA catheters, including the Long ACE, Graft ACE, PIVOT, and ACE.
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