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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 13 Results
productcode LNM PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
 
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Device
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PMA
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COAPTITE® Injectable Implant MERZ NORTH AMERICA, INC P040047 S068 12/15/2022
COAPTITE Injectable Impant MERZ NORTH AMERICA, INC P040047 S067 11/30/2022
COAPTITE® Injectable Implant MERZ NORTH AMERICA, INC P040047 S066 11/29/2022
Durasphere Injectable Bulking Agent CARBON MEDICAL TECHNOLOGIES, I P980053 S019 10/27/2022
Bulkamid Urethral Bulking System Axonics Modulation Technologie P170023 S012 10/26/2022
Bulkamid Urethral Bulking System Axonics Modulation Technologie P170023 S013 10/26/2022
Bulkamid Urethral Bulking System Axonics Modulation Technologie P170023 S009 08/05/2022
Bulkamid Urethral Bulking System Axonics Modulation Technologie P170023 S010 08/05/2022
Bulkamid Urethral Bulking System Axonics Modulation Technologie P170023 S011 08/05/2022
DEFLUX Injectable Gel Palette Life Sciences P000029 S094 03/22/2022
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