Spectranetics submits PMA for laser sheath

17 Jun 2002

Spectranetics Corp. (Colorado Springs, CO) applied to the FDA for premarket approval (PMA) of its excimer-laser sheath, a device used to remove pacemaker and implantable cardioverter defibrillator leads. The company based the PMA submission on the results of a clinical trial performed on more than 300 patients at 14 US sites. Recently expanded to 20 sites, the trial will continue during the FDA PMA review.
Courtesy of Laser Focus World