Extract to table

All promotional activities must remain within the boundaries of this cleared indication

Where a device is intended for use by persons other than healthcare professionals, labeling must bear adequate warnings against uses or methods of use that are dangerous to health, as well as appropriate cautionary statements

Even for prescription devices, promotional materials directed at healthcare professionals must include adequate risk and warning information to enable informed prescribing decisions

For the Pulsar™ CRM System, given the planned October 1, 2024 launch date, all launch-ready promotional materials must be submitted via Form 2253 on or before October 1, 2024

Any new or revised promotional material created after the initial submission must be filed via Form 2253 at the time of its first dissemination

Fair Balance Requirements All promotional materials for the Pulsar™ CRM System must present a fair balance of information relating to the Device's benefits and its risks, side effects, contraindications, and warnings