FDA 510(k) PMA

Database of Premarket Approvals

PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).
PMA requirements apply to Class III devices, the most stringent regulatory category for medical devices. The latest PMA approved devices are listed below. Search the PMA database here.

Latest PMA Approvals

Device NameManufacturerDate
P100016 S014
Carl Zeiss Meditec Production05/13/2022
P100021 S104
Medtronic Vascular05/13/2022
P190006 S055
Axonics Modulation Technologie05/13/2022
P130022 S046
Nevro Corporation05/13/2022
P830055 S287
DEPUY, INC.05/13/2022
P210032
W. L. Gore & Associates, Inc.05/13/2022
P100022 S039
Cook Ireland, Ltd.05/13/2022
P180046 S055
Axonics Modulation Technologie05/13/2022
P840001 S499
MEDTRONIC NEUROMODULATION05/13/2022
P160043 S055
MEDTRONIC VASCULAR05/12/2022
P190002 S006
SALUDA MEDICAL PTY LTD05/12/2022
P860004 S391
MEDTRONIC Inc.05/12/2022
P840001 S516
MEDTRONIC NEUROMODULATION05/12/2022
P180007 S009
Gyrus ACMI, Inc.05/12/2022
P960009 S426
MEDTRONIC Inc.05/12/2022
P080025 S251
MEDTRONIC NEUROMODULATION05/12/2022
P970004 S362
MEDTRONIC NEUROMODULATION05/12/2022
P080025 S257
MEDTRONIC NEUROMODULATION05/12/2022
P970004 S356
MEDTRONIC NEUROMODULATION05/12/2022
P930039 S242
Medtronic, Inc.05/11/2022
P090013 S321
Medtronic, Inc05/11/2022
P170038 S010
Abbott05/11/2022
P870024 S062
CooperVision, Inc.05/10/2022
P840001 S515
MEDTRONIC NEUROMODULATION05/10/2022
P970004 S361
MEDTRONIC NEUROMODULATION05/10/2022
P050031 S009
CooperVision, Inc.05/10/2022
P860004 S390
MEDTRONIC Inc.05/10/2022
P080025 S256
MEDTRONIC NEUROMODULATION05/10/2022
P980035 S715
MEDTRONIC Inc.05/10/2022
P100047 S197
Medtronic05/10/2022
P100034 S029
Novocure GmbH05/10/2022
P960009 S425
MEDTRONIC Inc.05/10/2022
P160029 S014
PHILIPS MEDICAL SYSTEMS, INC.05/09/2022
P050006 S099
W.L. GORE & ASSOCIATES,INC05/09/2022
P920048 S023
HOLOGIC, INC.05/09/2022
P180014 S008
XVIVO Perfusion, Inc.05/09/2022
P210029
Hologic, Inc.05/09/2022
P180014 S009
XVIVO Perfusion, Inc.05/09/2022
P180047 S015
DiaSorin, Inc.05/06/2022
P180049 S008
DiaSorin Inc.05/06/2022
P180045 S008
DiaSorin Inc.05/06/2022
P180038 S011
DiaSorin Inc.05/06/2022
P100010 S127
Medtronic CryoCath LP05/06/2022
P190017 S005
DiaSorin Inc05/06/2022
P180039 S010
DiaSorin Inc.05/06/2022
P110035 S067
Boston Scientific Corp.05/06/2022
P140028 S073
BOSTON SCIENTIFIC CORPORATION05/06/2022
P980037 S088
Boston Scientific Corp.05/06/2022
P180011 S049
Boston Scientific Corp.05/06/2022
P180048 S008
DiaSorin Inc.05/06/2022
P130013 S047
Boston Scientific Corp.05/06/2022
P150003 S085
BOSTON SCIENTIFIC CORPORATION05/06/2022
P110019 S120
ABBOTT VASCULAR05/06/2022
P170019 S032
Foundation Medicine, Inc.05/06/2022
P050050 S021
DJO Global05/06/2022
P160013 S009
TransMedics, Inc05/06/2022
P180050 S003
CVRx, INC.05/05/2022
P050037 S114
MERZ NORTH AMERICA, INC05/05/2022
P860004 S389
MEDTRONIC Inc.05/05/2022
P910001 S115
SPECTRANETICS CORP.05/05/2022
P070026 S097
DEPUY ORTHOPAEDICS, INC.05/05/2022
P190017 S004
DiaSorin Inc05/05/2022
P900033 S099
Integra LifeSciences Corp.05/05/2022
P050052 S135
MERZ NORTH AMERICA, INC05/05/2022
P180049 S007
DiaSorin Inc.05/05/2022
P180047 S014
DiaSorin, Inc.05/05/2022
P180045 S007
DiaSorin Inc.05/05/2022
P180048 S007
DiaSorin Inc.05/05/2022
P180038 S010
DiaSorin Inc.05/05/2022
P210022
Abbott Molecular, Inc.05/05/2022
P090016 S048
MERZ NORTH AMERICA, INC05/05/2022
P180039 S009
DiaSorin Inc.05/05/2022
P160048 S018
Senseonics, Incorporated05/04/2022
P030016 S043
STAAR Surgical Company05/04/2022
P150035 S001
Abbott Medical05/04/2022
P980016 S815
MEDTRONIC CARDIAC RHYTHM DISEA05/03/2022
P920015 S268
MEDTRONIC Inc.05/03/2022
P150030 S020
Smith & Nephew, Inc.05/03/2022
P190018 S019
Alcon Laboratories, LLC05/03/2022
P980035 S714
MEDTRONIC Inc.05/03/2022
P080011 S145
CooperVision, Inc.05/03/2022
P080006 S171
MEDTRONIC Inc.05/03/2022
P140026 S019
SILK ROAD MEDICAL, INC05/03/2022
P950020 S122
Boston Scientific Corp.05/03/2022
P210035
Orthofix US LLC05/03/2022
P150033 S138
MEDTRONIC Inc.05/03/2022
P010031 S782
MEDTRONIC CARDIAC RHYTHM DISEA05/03/2022
P010015 S497
MEDTRONIC Inc.05/03/2022
P200028 S009
Medtronic Inc.05/02/2022
P120010 S141
MEDTRONIC Inc.04/29/2022
P150001 S098
MEDTRONIC MINIMED04/29/2022
P110010 S194
Boston Scientific Corp.04/29/2022
P160007 S044
MEDTRONIC MINIMED04/29/2022
P150029 S038
MEDTRONIC MINIMED04/29/2022
P150019 S065
MEDTRONIC MINIMED04/29/2022
P160017 S100
MEDTRONIC MINIMED, INC.04/29/2022
P910018 S033
KANEKA PHARMA AMERICA CORP.04/29/2022
P970051 S208
Cochlear Americas04/29/2022
P130016 S046
Cochlear Americas04/29/2022
P130021 S109
Medtronic, Inc.04/29/2022
P130008 S074
INSPIRE MEDICAL SYSTEMS04/29/2022
P140026 S016
SILK ROAD MEDICAL, INC04/28/2022
P150021 S057
Abbott Diabetes Care Inc.04/28/2022
P850010 S101
INTEGRA LIFESCIENCES CORPORATI04/28/2022
P840062 S084
INTEGRA LIFESCIENCES CORP.04/28/2022
P110033 S066
Allergan04/28/2022
P050047 S085
Allergan04/28/2022
P160030 S051
ABBOTT DIABETES CARE INC.04/28/2022
P890003 S453
Medtronic, Inc.04/28/2022
P900056 S199
Boston Scientific Corp.04/28/2022
P160017 S099
MEDTRONIC MINIMED, INC.04/28/2022
P150001 S097
MEDTRONIC MINIMED04/28/2022
P150001 S096
MEDTRONIC MINIMED04/28/2022
P080012 S072
FLOWONIX MEDICAL, INC.04/28/2022
P810006 S098
INTEGRA LIFESCIENCES CORPORATI04/28/2022
P160017 S098
MEDTRONIC MINIMED, INC.04/28/2022
P080011 S143
CooperVision, Inc.04/27/2022
P830055 S288
DEPUY, INC.04/27/2022
P130026 S078
St. Jude Medical04/27/2022
P030047 S044
Cordis US Corporation04/27/2022
P180051 S001
TransMedics, Inc.04/27/2022
P040045 S124
VISTAKON, DIVISION OF JOHNSON04/27/2022
P180027 S005
MicroVention, Inc.04/26/2022
P010015 S496
MEDTRONIC Inc.04/26/2022
P010031 S781
MEDTRONIC CARDIAC RHYTHM DISEA04/26/2022
P180050 S005
CVRx, INC.04/26/2022
P970004 S360
MEDTRONIC NEUROMODULATION04/26/2022
P980016 S814
MEDTRONIC CARDIAC RHYTHM DISEA04/26/2022
P080025 S255
MEDTRONIC NEUROMODULATION04/26/2022
P980035 S713
MEDTRONIC Inc.04/26/2022
P150048 S064
EDWARDS LIFESCIENCES, LLC.04/26/2022
P040021 S050
Abbott Medical04/26/2022
P150033 S137
MEDTRONIC Inc.04/26/2022
P040044 S091
Cordis US Corporation04/25/2022
P180037 S009
Bard Peripheral Vascular, Inc.04/22/2022
P170012 S028
Biom'Up France SAS04/22/2022
P890003 S452
Medtronic, Inc.04/21/2022
P120017 S030
MEDTRONIC Inc.04/21/2022
P010031 S780
MEDTRONIC CARDIAC RHYTHM DISEA04/21/2022
P980035 S712
MEDTRONIC Inc.04/21/2022
P930039 S241
Medtronic, Inc.04/21/2022
P920015 S267
MEDTRONIC Inc.04/21/2022
P900061 S168
MEDTRONIC CARDIAC RHYTHM DISEA04/21/2022
P980016 S812
MEDTRONIC CARDIAC RHYTHM DISEA04/21/2022
P950024 S103
MEDTRONIC Inc.04/21/2022
P850089 S161
MEDTRONIC CARDIAC RHYTHM DISEA04/21/2022
P090013 S320
Medtronic, Inc04/21/2022
P080006 S170
MEDTRONIC Inc.04/21/2022
P060039 S110
MEDTRONIC Inc.04/21/2022
P030036 S137
MEDTRONIC CARDIAC RHYTHM DISEA04/21/2022
P980050 S137
MEDTRONIC Inc.04/21/2022
P830061 S206
MEDTRONIC CARDIAC RHYTHM DISEA04/21/2022
P150033 S136
MEDTRONIC Inc.04/21/2022
P010015 S495
MEDTRONIC Inc.04/21/2022
P180046 S052
Axonics Modulation Technologie04/20/2022
P850010 S100
INTEGRA LIFESCIENCES CORPORATI04/20/2022
P100016 S013
Carl Zeiss Meditec Production04/20/2022
P170008 S039
Medinol, Ltd.04/20/2022
P000053 S125
Boston Scientific Corp.04/20/2022
P190006 S052
Axonics Modulation Technologie04/20/2022
P190002 S004
SALUDA MEDICAL PTY LTD04/20/2022
N16895 S104
Bausch & Lomb, Inc.04/20/2022
N970012 S191
Boston Scientific Corp.04/20/2022
P160043 S059
MEDTRONIC VASCULAR04/20/2022
P150036 S062
EDWARDS LIFESCIENCES, LLC.04/20/2022
P190023 S007
Abbott Medical04/20/2022
P160042 S017
PROLLENIUM MEDICAL TECHNOLOGIE04/20/2022
P130021 S113
Medtronic, Inc.04/19/2022
P110013 S116
Medtronic Vascular04/19/2022
P030009 S107
MEDTRONIC IRELAND04/19/2022
P140003 S088
ABIOMED, INC.04/19/2022
P170011 S035
Abiomed, Inc.04/19/2022
P210006
Vascutek Ltd.04/19/2022
P170008 S041
Medinol, Ltd.04/19/2022
P100040 S051
Medtronic Vascular04/19/2022
P100021 S103
Medtronic Vascular04/19/2022

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