FDAnicotine

0% found this document useful (0 votes)

189 views14 pages

This letter from the FDA indicates that a medical device submission for the Brainsway Deep TMS System has been reviewed and found to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed for an additional intended use of aiding in short-term smoking cessation. The document provides details on the device, its classification and regulation, a summary of the indications for use, and conditions for marketing.

0% found this document useful (0 votes)

189 views14 pages

This letter from the FDA indicates that a medical device submission for the Brainsway Deep TMS System has been reviewed and found to be substantially equivalent to legally marketed predicate…