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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 NameBETA-CATH(TM) SYSTEM
Classification Nameintravascular radiation delivery system
Generic Nameintravascular brachytherapy system
ApplicantNOVOSTE CORP.
PMA NumberP000018
Supplement NumberS003
Date Received12/19/2000
Decision Date04/24/2001
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the post-approval study protocol for the beta-cath(tm) system. The post-approval study is intended to verify that the corrective actions, intended to help minimize the incidence of device failures and malfunctions seen during the premarket clinical investigation, are successful in reducing the device failure and malfunction rate.
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