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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.
 
DeviceCORDIS ORION STEERABLE PTCA BALLOON CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantCORDIS CORP.
P.O. BOX 025700
MIAMI, FL 33102-5700
PMA NumberP890032
Supplement NumberS011
Date Received08/22/1991
Decision Date10/04/1991
Withdrawal Date 09/02/2008
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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