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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
Generic Nameintravascular brachytherapy system
ApplicantNOVOSTE CORP.
PMA NumberP000018
Supplement NumberS009
Date Received02/12/2001
Decision Date10/26/2001
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the revised source seed specification (2. 7 - 40 mci) for the beta-cath system.
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