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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 NumberS334
Date Received06/09/2021
Decision Date12/06/2021
Decision Approved
Product Code
QCZ[ Registered Establishments with QCZ ]
Advisory Committee Hematology
Supplement TypeNormal 180 Day Track No User Fee
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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