Spectranetics, FDA Discuss Laser Indication Approval After Panel Says No
This article was originally published in The Gray Sheet
Executive SummarySpectranetics plans to use a 50-patient Belgium study to shore up support for an indication covering its CVX-300 excimer laser catheter system for critical limb ischemia patients with lesions not crossable with a guidewire
You may also be interested in...
Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.