Colorado-based medical laser manufacturer Spectranetics Corp will pay the United States $4.9 million in civil damages, plus a $100,000 forfeiture, to resolve claims against the company, according to the Justice Department.
The company allegedly imported unapproved medical devices illegally, promoted products without FDA approval or clearance, and provided unapproved devices to physicians for use in patients.
Spectranetics manufactures, distributes, and sells medical lasers and related peripheral devices. Products include the CVX-300 Medical Laser and the CliRpath Turbo Laser Catheter, the TURBO elite laser ablation catheter, and the TURBO-Booster laser guide catheter.
In resolving this matter, the company has also entered a non-prosecution agreement. Under the agreement’s terms, the company has accepted responsibility for its conduct, has instituted remedial measures to prevent this conduct in the future, and will continue to cooperate in an ongoing criminal investigation.
Read the full release on the US Attorney’s Office, District of Colorado Web site.