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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.
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namepercutaneous transluminal angioplasty catheter
Regulation Number870.5100
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.