FDA Clears Boston Scientific Plants

The FDA has approved Boston Scientific's Quincy Distribution Center as a sterilization site for its Cutting Balloon microsurgical dilatation device product line, the company said.

The company's Letterkenny, Ireland, facility has received FDA approval to manufacture two versions of the company's Cutting Balloon product line for distribution in the U.S. market. Both approvals came in the form of premarket approval supplements and followed quality systems inspections at Boston Scientific facilities in California; Quincy, Mass.; and Letterkenny in which the company received no adverse observations from the FDA.

The Quincy facility will use electron-beam technology to sterilize the Cutting Balloon device. The Letterkenny facility received FDA approval to manufacture the Cutting Balloon Ultra2 device and the 2 cm Peripheral Cutting Balloon device for distribution in the U.S. market.