FDA approves Spectranetics PMA for manufacturing site change for CVX-300 laser system

Spectranetics Corporation (Nasdaq: SPNC) today announced that the Food and Drug Administration (FDA) has approved the Company's 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 following rapid expansion of the Company's business within the last five years, a period in which revenue has nearly tripled. The employees involved in the manufacturing of laser systems will move to the new manufacturing site, which is also located in Colorado Springs and further serves as corporate headquarters.

The process leading to this approval involved the submission of extensive documentation supporting the site change and an inspection of the Company's facility by FDA personnel. Obtaining this 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.

Shar Matin, Senior Vice President of Operations, Product Development and International, stated, "Completion of the manufacturing site change for our laser system is one of several key initiatives targeted at improving our operating efficiencies throughout the Company. We are pleased to have completed this effort, including a successful FDA inspection, and look forward to completing the consolidation of all product manufacturing, including the ELCA and SLS II products, by the end of this year."

Source:

 Spectranetics

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