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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 10 Results
productcode LNM PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
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Device
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PMA
Number
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Decision
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DEFLUX Injectable Gel Palette Life Sciences P000029 S086 12/19/2019
Solesta Injectable Gel Palette Life Sciences P100014 S023 12/19/2019
Coaptite lnjectable lmplant MERZ NORTH AMERICA, INC P040047 S055 11/06/2019
Deflux Injectable Gel Palette Life Sciences P000029 S085 08/29/2019
Solesta Injectable Gel Palette Life Sciences P100014 S022 08/29/2019
Durasphere Injectable Bulking Agent CARBON MEDICAL TECHNOLOGIES, I P980053 S017 08/29/2019
Macroplastique Implants UROPLASTY, LLC P040050 S012 07/15/2019
Coaptite MERZ NORTH AMERICA, INC P040047 S052 06/26/2019
Coaptite Injectable Implant MERZ NORTH AMERICA, INC P040047 S053 06/07/2019
Coaptite Injectable Implant MERZ NORTH AMERICA, INC P040047 S054 06/07/2019
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