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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode NPZ PMA Number p Decision Date From 1/1/2024 Decision Date To 1/1/2025
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PMA
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GEM 21S (GROWTH-FACTOR ENHANCED MATRIX Lynch Biologics LLC P040013 S031 03/22/2024
GEM21S® Growth Factor Enhanced Matrix Lynch Biologics LLC P040013 S030 02/14/2024
GEM21S Lynch Biologics LLC P040013 S029 01/04/2024
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