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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.
 
DeviceSCIMED PTCA CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
Applicant
SCIMED LIFE SYSTEMS, INC.
one scimed place
maple grove, MN 55311-1566
PMA NumberP860019
Supplement NumberS161
Date Received04/06/2000
Decision Date04/26/2000
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
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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