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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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, 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
Date Received09/28/2017
Decision Date09/20/2018
Decision Approved
Product Code
QCZ[ Registered Establishments with QCZ ]
Advisory Committee Hematology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S128 S129 S144 S161 S205 S221 S222 S223 S262 
S287 S288 S324 S333 S334 S335 S346 S350 S351 
S383 S392 S437 S457 S458 S460 S482 S502 S566 
S575 S576 S581 S623 S653 S665 S789 S841 S952 
S978 1054 1115 1271 
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