secwatch.observer — SEC 8-K summary
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Issuer:     AVITA Medical, Inc. (RCEL)
CIK:        0001762303
Form:       8-K
Filed at:   2023-10-02T23:59:59+00:00
Accession:  0000950170-23-050935
Event type: regulatory
Sentiment:  negative
Materiality: 0.70
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1762303/000095017023050935/0000950170-23-050935-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1762303/000095017023050935/rcel-20231002.htm
  HTML page:      https://secwatch.observer/filing/0000950170-23-050935

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer