Lol.
www.fda.gov/media/116379/download
Avita Medical Americas, LLC
Attention: Ron Lagerquist
Senior Director RA/QS
28159 Avenue Stanford, Suite 220
Valencia, CA 91355
Re:BP170122
Trade/Device Name: RECELL® Autologous Cell Harvesting
Device Filed: September 28, 2017
Amended: September 28, 2017, October 6, 2017, October 16, 2017, October 25, 2017,
November 15, 2017, December 4, 2017, December 18, 2017, June 18, 2018, July 2, 2018,
July 23, 2018, July 30, 2018, August 8, 2018, August 13, 2018, August 14, 2018, August 20,
2018, August 21, 2018, August 22, 2018, August 23, 2018, August 23, 2018, August 24,
2018, August 27, 2018, August 29, 2018, August 30, 2018, August 30, 2018, August 31,
2018, September 5, 2018, September 6, 2018, September 10, 2018, September 12, 2018,
September 14, 2018, September 17, 2018, September 19, 2018
Product Code: QCZ
Dear Mr. Lagerquist:
The Center for Biologics Evaluation and Research (CBER) of the Food and Drug
Administration (FDA) has completed its review of your premarket approval application (PMA)
for the RECELL® Autologous Cell Harvesting Device. This device is indicated for the
treatment of acute thermal burn wounds in patients 18 years of age and older. The RECELL®
Device is used by an appropriately-licensed healthcare professional at the patient’s point-ofcare to prepare autologous Regenerative Epidermal Suspension (RES™) for direct application
to acute partial-thickness thermal burn wounds or application in combination with meshed
autografting for acute full-thickness thermal burn wounds. We are pleased to inform you that
the PMA is approved. You may begin commercial distribution of the device in accordance with
the conditions of approval described below.
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