Guidant suspends atherectomy catheter:
This article was originally published in Clinica
Guidant's US subsidiary DVI has suspended shipments of AtheroCath-GTO following modifications to the atherectomy catheter. The company says the voluntary suspension follows a meeting with the FDA when the modifications and other, unnamed, regulatory issues were raised. The suspension will remain in place until a PMA supplement covering the modifications has been cleared by the FDA. Catheters already distributed are not affected.
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