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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
ApplicantEndologix, Inc.
11 Studebaker
Irvine, CA 92618
PMA NumberP970052
Supplement NumberS002
Date Received11/19/1997
Decision Date05/19/1998
Withdrawal Date03/30/2009
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modifications to the Guardian(TM) Balloon Coronary Dilatation Catheter.
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