Spectranetics Obtains FDA Approval for CVX-300 Laser System Manufacturing Site Change

Manufacturer of medical devices, Spectranetics has received premarket approval application (PMA) supplement from the Food and Drug Administration (FDA) related to a production site change for the CVX-300 laser system.

The laser system manufacturing sit change is part of the company’s plan to combine the entire product manufacturing into one proficient facility. The employees who manufacture laser systems will be shifted to the new production site that is also based in Colorado Springs. In addition, the new site will serve as corporate headquarters for the company’s operations.

The approval allows Spectranetics to expand its manufacturing abilities at the new site followed by the transfer of 510(k) solutions in 2009. In addition, the company would apply for an another PMA supplement to the FDA to change the manufacturing site for its rest of the products, namely the SLS II laser-assisted lead extraction series and the SLS II laser-assisted lead extraction family.