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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCORDIS ORION STEERABLE PTCA BALLOON CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameballoon catheter
Regulation Number870.5100
ApplicantCORDIS CORP.
PMA NumberP890032
Supplement NumberS019
Date Received11/22/1994
Decision Date12/13/1994
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
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