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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
PMA NumberP890032
Supplement NumberS018
Date Received12/20/1993
Decision Date08/04/1995
Withdrawal Date09/02/2008
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:ALTERNATE STERILIZATION SITE; ELIMINATION OF CHLOROFLUOROCARBONS FROM THE STERILIZATION PROCESS
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