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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.
 
DeviceGUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantABBOTT VASCULAR DEVICES
400 SAGINAW DR.
REDWOOD CITY, CA 94063
PMA NumberP910031
Supplement NumberS017
Date Received10/14/1997
Decision Date11/10/1997
Reclassified Date 10/08/2011
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change in the trade name from the LYNX(TM) to the Guardian(TM) Coronary Balloon Dilatation PTCA Catheter.
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