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Home » CELSION PROSTATE CANCER CATHETER KITS BACK ON THE MARKET
CELSION PROSTATE CANCER CATHETER KITS BACK ON THE MARKET
August 14, 2006
Celsion announced Aug. 11 that the FDA had approved its premarket approval supplement for its Prolieve thermodilatation disposable catheter system to treat prostate cancer, after a recall led the agency to request changes in the firm's manufacturing and inspection processes for the device.
The company said it has been cleared to sell the modified product again through its distributor, Boston Scientific, and will begin arranging shipments "immediately."
The firm May 4 initiated a recall of 2,930 kits manufactured at its Accellent Juarez, Mexico, plant. "We discovered that some catheters were failing to achieve or maintain pressure," a Celsion spokeswoman said.
The company made manufacturing changes to correct the inner manifold bond of the catheter, and the FDA expedited its approval process to allow the device back on the market, she added.
KEYWORDS FDAnews Device Daily Bulletin
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