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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 CATHETERS
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 NumberS175
Date Received07/12/2001
Decision Date08/14/2001
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change that strengthens a warning statement included in the directions for use manual. Specifically, the labeling statement is being modified to expand the information provided regarding the affect of re-processing or re-sterilization. The change applies to all directions for use manuals of currently marketed ptca catheters approved under this pma.
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