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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 NumberS008
Date Received02/02/2001
Decision Date10/26/2001
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the design of the sterile bag and fluid collection bag provided in the procedure accessory pack.
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