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FDA approves Spectranetics to change CVX-300 laser system manufacturing site

Spectranetics has received the Food and Drug Administration (FDA) approval for the premarket approval application (PMA) supplement requesting a manufacturing site change for the CVX-300 laser system.

The move of laser system manufacturing from its current location in Colorado Springs, Colorado, is part of a broader plan to consolidate all product manufacturing into a single, more efficiently designed facility.

The change follows rapid expansion of the company’s business within the last five years, a period in which revenue has nearly tripled.

The process leading to the approval involved the submission of extensive documentation supporting the site change and an inspection of the company’s facility by FDA personnel.

Obtaining the approval expands Spectranetics’ manufacturing capabilities at corporate headquarters after completing the transfer of 510(k) products in 2009.

The company expects to submit a separate PMA supplement to the FDA later this year requesting a manufacturing site change for its remaining products, the ELCA coronary atherectomy product line and the SLS II laser-assisted lead extraction product line.

Spectranetics Operations Product Development and International senior vice president Shar Matin said completion of the manufacturing site change for their laser system is one of several key initiatives targeted at improving their operating efficiencies throughout the company.