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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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New Search Biologics Premarket Approvals (PMAs) Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Device RECELL Autologous Cell Harvesting Device
Classification Namemechanical and enzymatic autologous skin processor for cell suspension, for stable vitiligo, with applicator
Generic Namemechanical and enzymatic autologous skin processor for cell suspension, for stable vitiligo, with applicator
Applicant
Avita Medical
28159 avenue stanford suite 220
Valencia, CA  91355 -2271
PMA NumberBP220799
Date Received12/19/2022
Decision Date06/16/2023
Decision Approved
Product Code
QWY[ Registered Establishments with QWY ]
Advisory Committee Hematology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S004 S005 S006 
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