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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 Pl.
Maple Grove, MN 55311
PMA NumberP860019
Supplement NumberS175
Date Received07/12/2001
Decision Date08/14/2001
Reclassified Date10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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