In the wake of an FDA warning letter that highlighted complaints of sparks and visible light during the operation of a laser system and an unspecified number of deaths reported with its devices, Colorado Springs, Colo.-based Spectranetics Corp. said it intends to respond "timely and fully" to the agency by Friday.
"We believe that the response will primarily involve updates in processes and documentation and will have no material impact on our business," a Spectranetics spokesperson told Medical Device Daily. Read More
