AVITA Medical receives FDA additional info request for RECELL GO PMA; launch pushed to mid-2024

AVITA Medical, Inc.

FDA placed RECELL GO PMA supplement on hold for ~4-6 months pending additional info.
Review will resume 180-day cycle upon complete response, with 90 days remaining.
Implied product launch is now between May 1 and July 1, 2024.
PMA was submitted June 30, 2023 under Breakthrough Device program.
Company received notice at halfway point of the 180-day review cycle.

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