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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 100 of 500 Results *
productcode LMH Decision Date To 08/05/2020
 
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belotero balance(r) dermal filler MERZ NORTH AMERICA, INC P090016 S034 09/07/2022
radiesse® injectable implant MERZ NORTH AMERICA, INC P050037 S115 09/02/2022
radiesse® injectable implant, radiesse® hands, rad... MERZ NORTH AMERICA, INC P050052 S136 09/02/2022
bellafill® dermal filler SUNEVA MEDICAL, INC. P020012 S041 08/05/2022
juvéderm ultra, ultra xc, juvéderm ultra xc Allergan P050047 S086 08/05/2022
voluma xc, vollure xc, volbella xc Allergan P110033 S067 08/05/2022
juvéderm volux xc Allergan P110033 S065 07/29/2022
sculptra and sculptra aesthetic Q-Med AB P030050 S035 07/25/2022
restylane injectable gels Q-Med AB P040024 S131 07/20/2022
sculptra, sculptra aesthetic Q-Med AB P030050 S037 06/27/2022
rha redensity, rha 2, rha 3, and rha 4 dermal fill... TEOXANE S.A. P170002 S021 06/14/2022
restylane refyne, restylane defyne and restylane k... Q-Med AB P140029 S033 05/27/2022
radiesse® injectable implant MERZ NORTH AMERICA, INC P050037 S114 05/05/2022
radiesse® injectable implant, including radiesse® ... MERZ NORTH AMERICA, INC P050052 S135 05/05/2022
belotero balance dermal filler and belotero balanc... MERZ NORTH AMERICA, INC P090016 S048 05/05/2022
juvéderm ultra, ultra xc and ultra plus xc, juvéde... Allergan P050047 S085 04/28/2022
juvéderm voluma xc, juvéderm vollure xc, juvéderm ... Allergan P110033 S066 04/28/2022
revanesse versa+ with lidocaine (1.0 ml and 1.2 ml... PROLLENIUM MEDICAL TECHNOLOGIE P160042 S017 04/20/2022
rha 2, rha 3, rha 4 dermal fillers TEOXANE S.A. P170002 S020 02/24/2022
bellafill dermal filler SUNEVA MEDICAL, INC. P020012 S039 02/17/2022
revanesse versa, revanesse versa + (with lidocaine... PROLLENIUM MEDICAL TECHNOLOGIE P160042 S013 02/08/2022
radiesse injectable implant MERZ NORTH AMERICA, INC P050037 S113 02/02/2022
radiesse injectable implant, including radiesse ha... MERZ NORTH AMERICA, INC P050052 S134 02/02/2022
bellafill dermal filler SUNEVA MEDICAL, INC. P020012 S040 01/21/2022
sculptra Q-Med AB P030050 S038 01/21/2022
rha® redensity™ TEOXANE S.A. P170002 S012 12/22/2021
restylane-l, restylane lyft, restylane silk Q-Med AB P040024 S129 12/14/2021
perlane, restylane Q-Med AB P040024 S130 12/14/2021
restylane® injectable gel Q-Med AB P040024 S128 12/09/2021
restylane® refyne, restylane® defyne, restylane® k... Q-Med AB P140029 S044 12/09/2021
belotero balance + lidocaine dermal filler, belote... MERZ NORTH AMERICA, INC P090016 S044 12/08/2021
belotero balance + lidocaine dermal filler, belote... MERZ NORTH AMERICA, INC P090016 S045 12/08/2021
restylane contour Q-Med AB P140029 S043 11/30/2021
sculptra and sculptra aesthetic Q-Med AB P030050 S034 11/23/2021
restylane, restylane lyft with lidocaine, restylan... Q-Med AB P040024 S123 11/16/2021
restylane refyne, restylane defyne, restylane kyss... Q-Med AB P140029 S042 10/27/2021
restylane® injectable gels Q-Med AB P040024 S124 10/22/2021
rha®4 dermal filler TEOXANE S.A. P170002 S019 10/22/2021
radiesse implant MERZ NORTH AMERICA, INC P050037 S112 10/21/2021
radiesse (+) lidocaine implant MERZ NORTH AMERICA, INC P050052 S132 10/21/2021
restylane refyne, restylane defyne, restylane kyss... Q-Med AB P140029 S040 10/19/2021
belotero balance + lidocaine MERZ NORTH AMERICA, INC P090016 S046 10/13/2021
juvéderm® volbella™ xc Allergan P110033 S062 09/10/2021
radiesse (+) injectable implant MERZ NORTH AMERICA, INC P050052 S129 09/01/2021
radiesse injectable implant MERZ NORTH AMERICA, INC P050037 S110 08/27/2021
radiesse injectable implant, radiesse hands, and r... MERZ NORTH AMERICA, INC P050052 S128 08/27/2021
restylane injectable gel Q-Med AB P040024 S126 08/25/2021
rha 2, rha 3, rha dermal fillers TEOXANE S.A. P170002 S018 08/13/2021
juvederm gel implants Allergan P050047 S080 07/21/2021
juvéderm hyaluronate gel implants Allergan P050047 S082 07/21/2021
juvederm injectable gel Allergan P110033 S058 07/21/2021
juvéderm voluma xc, juvéderm vollure xc, and juvéd... Allergan P110033 S061 07/21/2021
restylane® contour Q-Med AB P140029 S032 06/28/2021
radiesse (+) lidocaine dermal filler MERZ NORTH AMERICA, INC P050052 S131 06/25/2021
juvéderm hyaluronate gel implants Allergan P050047 S081 06/23/2021
juvéderm hyaluronate gel implants Allergan P110033 S060 06/23/2021
restylane refyne, restylane defyne, restylane kyss... Q-Med AB P140029 S035 06/11/2021
bellafill dermal filler SUNEVA MEDICAL, INC. P020012 S037 06/08/2021
radiesse injectable implant MERZ NORTH AMERICA, INC P050037 S111 06/08/2021
radiesse injectable implant and radiesse hands MERZ NORTH AMERICA, INC P050052 S130 06/08/2021
juvederm volbella xc Allergan P110033 S053 05/28/2021
rha 2, rha 3, rha 4 dermal fillers TEOXANE S.A. P170002 S017 05/26/2021
sculptra (injectable poly-l lactic acid) and sculp... Q-Med AB P030050 S032 05/18/2021
bellafill dermal filler SUNEVA MEDICAL, INC. P020012 S038 05/14/2021
revanesse lips+ 1.2 ml PROLLENIUM MEDICAL TECHNOLOGIE P160042 S014 05/07/2021
rha 2, rha 3, rha 4 dermal fillers TEOXANE S.A. P170002 S016 04/30/2021
sculptra and sculptra aesthetic Q-Med AB P030050 S036 04/28/2021
rha 2, rha 3, rha 4 dermal fillers TEOXANE S.A. P170002 S015 04/26/2021
revanesse versa, revanesse versa+, revanesse lips+ PROLLENIUM MEDICAL TECHNOLOGIE P160042 S015 04/16/2021
rha 2, rha 3, rha 4 dermal fillers TEOXANE S.A. P170002 S014 04/15/2021
restylane kysse injectable gel Q-Med AB P140029 S037 04/14/2021
restylane kysse injectable gel Q-Med AB P140029 S038 04/13/2021
rha 2, rha 3, rha 4 TEOXANE S.A. P170002 S013 03/19/2021
restylane refyne, restylane defyne, restylane kyss... Q-Med AB P140029 S036 03/03/2021
rha 2, rha 3, rha 4 dermal fillers TEOXANE S.A. P170002 S010 02/10/2021
restylane defyne Q-Med AB P140029 S027 01/29/2021
belotero balance dermal filler, belotero balance +... MERZ NORTH AMERICA, INC P090016 S042 12/22/2020
radiesse injectable implant MERZ NORTH AMERICA, INC P050037 S099 12/21/2020
radiesse injectable implant and radiesse (+) lidoc... MERZ NORTH AMERICA, INC P050052 S116 12/21/2020
restylane kysse injectable gel Q-Med AB P140029 S029 12/21/2020
sculptra and sculptra aesthetic (injectable poly-l... Q-Med AB P030050 S033 12/18/2020
restylane refyne, restylane defyne, restylane kyss... Q-Med AB P140029 S031 12/04/2020
juvéderm ultra, juvéderm ultra xc, juvéderm ultra ... Allergan P050047 S079 11/25/2020
juvéderm voluma xc, juvéderm vollure xc, and juvéd... Allergan P110033 S057 11/25/2020
restylane, restylane-l, perlane, restylane lyft wi... Q-Med AB P040024 S121 11/06/2020
restylane refyne, restylane defyne, and restylane ... Q-Med AB P140029 S034 11/06/2020
belotero balance MERZ NORTH AMERICA, INC P090016 S043 10/29/2020
juvéderm injectable gel implants Allergan P050047 S078 10/28/2020
juvéderm injectable gel implants Allergan P110033 S056 10/28/2020
radiesse injectable implant MERZ NORTH AMERICA, INC P050037 S109 10/23/2020
radiesse injectable implant, radiesse hands, and r... MERZ NORTH AMERICA, INC P050052 S127 10/23/2020
radiesse injectable implant MERZ NORTH AMERICA, INC P050037 S107 10/15/2020
radiesse injectable implant, radiesse hands, and r... MERZ NORTH AMERICA, INC P050052 S125 10/15/2020
restylane, perlane, restylane-l, restylane lyft wi... Q-Med AB P040024 S120 10/14/2020
radiesse injectable implant MERZ NORTH AMERICA, INC P050037 S108 10/14/2020
radiesse injectable implant, radiesse hands and ra... MERZ NORTH AMERICA, INC P050052 S126 10/14/2020
restylane refyne, restylane defyne, restylane kyss... Q-Med AB P140029 S030 10/14/2020
revanesse versa+ PROLLENIUM MEDICAL TECHNOLOGIE P160042 S012 10/13/2020
radiesse injectable implant MERZ NORTH AMERICA, INC P050037 S102 10/02/2020
radiesse injectable implant, radiesse hands, and r... MERZ NORTH AMERICA, INC P050052 S120 10/02/2020
 
 
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