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
P030035 S191
Abbott Medical09/30/2022
P990081 S047
VENTANA MEDICAL SYSTEMS, INC.09/30/2022
P100047 S196
Medtronic09/30/2022
P140033 S075
Abbott Medical09/30/2022
P970013 S091
Abbott Medical09/30/2022
P910023 S447
Abbott Medical09/30/2022
P130022 S043
Nevro Corporation09/30/2022
P030054 S401
Abbott Medical09/30/2022
P880086 S325
Abbott Medical09/30/2022
P210003 S001
Abbott Laboratories09/30/2022
P990025 S070
BIOSENSE WEBSTER, INC.09/30/2022
P950020 S126
Boston Scientific Corp.09/30/2022
P950005 S085
Biosense Webster, Inc09/30/2022
P930036 S020
SIEMENS HEALTHCARE DIAGNOSTICS09/30/2022
P040036 S090
BIOSENSE WEBSTER, INC.09/30/2022
P030031 S128
BIOSENSE WEBSTER, INC.09/30/2022
P010068 S070
BIOSENSE WEBSTER, INC.09/30/2022
P990071 S056
BIOSENSE WEBSTER, INC.09/30/2022
P110029 S038
Abbott Laboratories09/30/2022
P050051 S046
ABBOTT LABORATORIES INC09/30/2022
P040024 S134
Q-Med AB09/30/2022
P180034 S006
Philips Image Guided Therapy C09/29/2022
P190027 S003
Philips Image Guided Therapy C09/29/2022
P210020 S006
Urotronic, Inc.09/29/2022
P110013 S117
Medtronic Vascular09/29/2022
P160043 S060
MEDTRONIC VASCULAR09/29/2022
P150030 S027
Smith & Nephew, Inc.09/29/2022
P210006 S003
Vascutek Ltd.09/29/2022
P980006 S035
Bausch & Lomb, Inc.09/29/2022
P050050 S025
DJO Global09/29/2022
P890055 S083
Intera Oncology09/29/2022
P860004 S399
MEDTRONIC Inc.09/28/2022
N970003 S276
Boston Scientific Corp.09/27/2022
P130021 S122
Medtronic, Inc.09/27/2022
P170019 S038
Foundation Medicine, Inc.09/27/2022
P170018 S014
Physio-Control, Inc09/27/2022
P030005 S221
GUIDANT CORP.09/27/2022
P010012 S557
Boston Scientific Corp.09/27/2022
P150012 S130
BOSTONSCIENTIFIC09/27/2022
P110042 S172
BOSTON SCIENTIFIC CORPORATION09/27/2022
P960040 S481
BOSTON SCIENTIFIC09/27/2022
P970051 S212
Cochlear Americas09/26/2022
P050006 S102
W.L. GORE & ASSOCIATES,INC09/23/2022
P150036 S064
EDWARDS LIFESCIENCES, LLC.09/23/2022
P970004 S368
MEDTRONIC NEUROMODULATION09/23/2022
P200015 S027
Edwards Lifesciences, LLC09/23/2022
P140031 S144
EDWARDS LIFESCIENCES, LLC.09/23/2022
P860057 S209
EDWARDS LIFESCIENCES, LLC.09/23/2022
P100010 S130
Medtronic CryoCath LP09/23/2022
P140031 S145
EDWARDS LIFESCIENCES, LLC.09/23/2022
P860003 S108
Mallinckrodt Pharmaceuticals I09/23/2022
P080025 S263
MEDTRONIC NEUROMODULATION09/23/2022
P890023 S049
THE COOPER COMPANIES09/23/2022
P150048 S068
EDWARDS LIFESCIENCES, LLC.09/23/2022
P040045 S127
VISTAKON, DIVISION OF JOHNSON09/22/2022
P030011 S082
SYNCARDIA SYSTEMS, LLC09/22/2022
P190016 S005
Tusker Medical, Inc.09/22/2022
P180035 S011
CooperVision, Inc.09/22/2022
N18033 S109
VISTAKON, JOHNSON & JOHNSON VI09/22/2022
P990023 S018
ALCON LABORATORIES09/22/2022
P860004 S398
MEDTRONIC Inc.09/22/2022
P150009 S008
ANGEL MEDICAL SYSTEMS INC.09/21/2022
P010015 S506
MEDTRONIC Inc.09/21/2022
P980035 S729
MEDTRONIC Inc.09/21/2022
P190032 S007
Foundation Medicine Inc.09/21/2022
P190032 S006
Foundation Medicine Inc.09/21/2022
P200016 S001
Foundation Medicine, Inc.09/21/2022
P160045 S031
LIFE TECHNOLOGIES CORPORATION09/21/2022
P150030 S026
Smith & Nephew, Inc.09/21/2022
P200006 S002
Foundation Medicine, Inc.09/21/2022
P150005 S071
Boston Scientific Corp.09/21/2022
P020025 S136
BOSTON SCIENTIFIC09/21/2022
P920047 S128
Boston Scientific Corp.09/21/2022
P210005 S001
AcuFocus, Inc.09/20/2022
P210005 S002
AcuFocus, Inc.09/20/2022
P060022 S030
Bausch & Lomb, Inc.09/20/2022
P200031 S001
TransMedics, Inc.09/19/2022
P080011 S141
CooperVision, Inc.09/19/2022
P160045 S037
LIFE TECHNOLOGIES CORPORATION09/19/2022
P010031 S802
MEDTRONIC CARDIAC RHYTHM DISEA09/19/2022
P980016 S836
MEDTRONIC CARDIAC RHYTHM DISEA09/19/2022
P980016 S835
MEDTRONIC CARDIAC RHYTHM DISEA09/19/2022
P010031 S801
MEDTRONIC CARDIAC RHYTHM DISEA09/19/2022
P150033 S152
MEDTRONIC Inc.09/16/2022
P980035 S728
MEDTRONIC Inc.09/16/2022
P990034 S043
MEDTRONIC Inc.09/16/2022
P200020 S001
Lenstec, Inc.09/16/2022
P860004 S397
MEDTRONIC Inc.09/16/2022
P020003 S011
COLOPLAST CORP.09/16/2022
P930039 S245
Medtronic, Inc.09/15/2022
P920015 S271
MEDTRONIC Inc.09/15/2022
P090013 S324
Medtronic, Inc09/15/2022
P150033 S151
MEDTRONIC Inc.09/15/2022
P180035 S010
CooperVision, Inc.09/15/2022
P160043 S058
MEDTRONIC VASCULAR09/15/2022
P950037 S238
BIOTRONIK, INC.09/15/2022
P840064 S078
ALCON LABORATORIES09/15/2022
P890047 S059
Alcon Research, Ltd.09/15/2022
P070008 S139
BIOTRONIK, INC.09/15/2022
P100045 S063
Abbott Medical09/15/2022
P950020 S125
Boston Scientific Corp.09/15/2022
P830061 S208
MEDTRONIC CARDIAC RHYTHM DISEA09/15/2022
P990023 S017
ALCON LABORATORIES09/15/2022
P980035 S730
MEDTRONIC Inc.09/15/2022
P110019 S122
ABBOTT VASCULAR09/14/2022
P220003
Edwards LifeSciences LLC09/14/2022
P890047 S058
Alcon Research, Ltd.09/13/2022
P160053 S005
ENDOMAGNETICS LTD.09/13/2022
P150030 S025
Smith & Nephew, Inc.09/13/2022
P140018 S034
MEDTRONIC VASCULAR INC09/13/2022
P020004 S191
W.L. GORE & ASSOCIATES,INC09/13/2022
P080025 S268
MEDTRONIC NEUROMODULATION09/13/2022
P840001 S528
MEDTRONIC NEUROMODULATION09/13/2022
P970004 S373
MEDTRONIC NEUROMODULATION09/13/2022
P840064 S077
ALCON LABORATORIES09/13/2022
P150036 S063
EDWARDS LIFESCIENCES, LLC.09/12/2022
P860057 S208
EDWARDS LIFESCIENCES, LLC.09/12/2022
P130008 S085
INSPIRE MEDICAL SYSTEMS09/12/2022
P150048 S067
EDWARDS LIFESCIENCES, LLC.09/12/2022
P010068 S069
BIOSENSE WEBSTER, INC.09/09/2022
P950005 S084
Biosense Webster, Inc09/09/2022
P960058 S156
ADVANCED BIONICS09/09/2022
P010032 S190
Abbott Medical09/09/2022
P100009 S047
Abbott Medical09/09/2022
P150030 S014
Smith & Nephew, Inc.09/09/2022
P030031 S127
BIOSENSE WEBSTER, INC.09/09/2022
P040036 S089
BIOSENSE WEBSTER, INC.09/09/2022
P990025 S069
BIOSENSE WEBSTER, INC.09/09/2022
P030054 S402
Abbott Medical09/09/2022
P910023 S448
Abbott Medical09/09/2022
P130021 S121
Medtronic, Inc.09/09/2022
P150048 S065
EDWARDS LIFESCIENCES, LLC.09/08/2022
P100047 S200
Medtronic09/08/2022
P180046 S059
Axonics Modulation Technologie09/08/2022
P190006 S059
Axonics Modulation Technologie09/08/2022
P860004 S396
MEDTRONIC Inc.09/08/2022
P110043 S013
ABBOTT VASCULAR-CARDIAC THERAP09/07/2022
P960009 S437
MEDTRONIC Inc.09/07/2022
P090016 S034
MERZ NORTH AMERICA, INC09/07/2022
P970020 S086
ABBOTT VASCULAR INC.09/07/2022
P190006 S060
Axonics Modulation Technologie09/07/2022
P180046 S060
Axonics Modulation Technologie09/07/2022
P840001 S526
MEDTRONIC NEUROMODULATION09/07/2022
P020047 S075
ABBOTT VASCULAR09/07/2022
P150016 S022
NEOMEND, INC.09/07/2022
P140003 S105
ABIOMED, INC.09/06/2022
P180036 S014
Impulse Dynamics (USA), Inc.09/06/2022
P150033 S150
MEDTRONIC Inc.09/06/2022
P010047 S067
NEOMEND, INC.09/06/2022

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