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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 3.5F SYSTEM
Classification Nameintravascular radiation delivery system
ApplicantNOVOSTE CORP.
PMA NumberP000018
Supplement NumberS026
Date Received10/18/2002
Decision Date11/13/2002
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the user's manual, user's guide and customer training to include additional information on scenarios where the beta-rail 3. 5f delivery catheter tip may be subjected to excessive force and the techniques for avoiding and/or resolving these scenarios.
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