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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 3.5F SYSTEM - 60 MM
Classification Nameintravascular radiation delivery system
ApplicantNOVOSTE CORP.
PMA NumberP000018
Supplement NumberS028
Date Received01/06/2003
Decision Date06/25/2003
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the 60 mm beta-cath 3. 5f system. The device, as modified, is indicated to deliver beta radiation to the site of successful percutaneous coronary intervention (pci) for the treatment of in-stent restenosis in native coronary arteries with discrete lesions (treatable with a 20 mm balloon for the 30 mm and 40 mm systems and injury areas up to 40 mm for the 60 mm system) in a reference vessel diameter ranging from 2. 7 mm to 4. 0 mm.
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