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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA 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, with applicator
Generic Namemechanical and enzymatic autologous skin processor for cell suspension, with applicator
Applicant
Avita Medical
28159 avenue stanford suite 220
Valencia, CA  91355 -2271
PMA NumberBP170122
Supplement NumberS437
Date Received05/13/2022
Decision Date06/09/2022
Decision 30-Day Notice - No 135-Day Supplement Needed
Product Code
QCZ[ Registered Establishments with QCZ ]
Advisory Committee Hematology
Supplement Type 30-Day Notice
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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