AVITA Medical Submits Response to FDA, Resuming Review Clock for RECELL GO PMA Supplement
VALENCIA, Calif., Feb. 29, 2024 (GLOBE NEWSWIRE) — AVITA Medical, Inc. (NASDAQ:RCEL, ASX:AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced it has submitted its response to the U.S. Food and Drug Administration (FDA) for additional information requested in connection to its premarket approval (PMA) supplement for RECELL GO™. This submission resumes the substantive interactive review process under the Breakthrough Devices Program.