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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 SYSTEM
Classification Nameintravascular radiation delivery system
ApplicantNOVOSTE CORP.
PMA NumberP000018
Supplement NumberS025
Date Received10/15/2002
Decision Date01/06/2003
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the design specification and manufacturing process for the beta-rail 3. 5f delivery catheter (with 30 and 40 mm indicator source train).
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