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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 NameNOVOSTE BETA-CATH 3.5 SYSTEM
Classification Nameintravascular radiation delivery system
ApplicantNOVOSTE CORP.
PMA NumberP000018
Supplement NumberS031
Date Received02/14/2003
Decision Date03/17/2003
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional inspection step in the manufacturing process of the beta-rail 3. 5f delivery catheter.
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