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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 NameRAPTORAIL PTCA DILATATION CATHETER (RX)
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namepercutaneous transluminal angioplasty catheter
Regulation Number870.5100
ApplicantCORDIS CORP.
PMA NumberP880003
Supplement NumberS083
Date Received02/01/2002
Decision Date02/12/2002
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the quality plan: 1) the addition of a 100% visual marker band placement verification; 2) the addition of a qc audit for marker band placement verification; and 3) the addition of a qc functional test for inflation/deflation time verification.
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