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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.
Classification Nameintravascular radiation delivery system
Generic Namepercutaneous catheter, radionuclide brachytherapy source, remote controlled radionuclide applicator system
PMA NumberP000052
Supplement NumberS021
Date Received09/30/2003
Decision Date03/04/2004
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the p-32 source wire manufacturing process to incorporate an automated source wire assembly station (swas) as an alternate process for final assembly of p-32 source wires.