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
P020004 S175
W.L. GORE & ASSOCIATES,INC07/31/2020
P040043 S116
W. L. GORE & ASSOCIATES, INC.07/31/2020
P100022 S036
Cook Ireland, Ltd.07/31/2020
P120011 S020
IDEALIMPLANT07/31/2020
P190015 S001
Bolton Medical Inc.07/31/2020
P860003 S102
Mallinckrodt Pharmaceuticals I07/31/2020
N970012 S179
Boston Scientific Corp.07/30/2020
P000040 S039
Boston Scientific Corp.07/30/2020
P000053 S114
Boston Scientific Corp.07/30/2020
P020056 S051
Allergan07/30/2020
P040046 S032
Allergan07/30/2020
P050037 S106
MERZ NORTH AMERICA, INC07/30/2020
P050052 S124
MERZ NORTH AMERICA, INC07/30/2020
P080025 S197
MEDTRONIC NEUROMODULATION07/30/2020
P110029 S033
Abbott Laboratories07/30/2020
P110035 S060
Boston Scientific Corp.07/30/2020
P140028 S061
BOSTON SCIENTIFIC CORPORATION07/30/2020
P150021 S049
Abbott Diabetes Care Inc.07/30/2020
P150033 S078
MEDTRONIC Inc.07/30/2020
P160030 S043
ABBOTT DIABETES CARE INC.07/30/2020
P180011 S034
Boston Scientific Corp.07/30/2020
P180031 S001
Stryker Neurovascular07/30/2020
P970004 S302
MEDTRONIC NEUROMODULATION07/30/2020
P990074 S044
Allergan07/30/2020
P010015 S442
MEDTRONIC Inc.07/29/2020
P050027 S025
KARL STORZ ENDOSCOPY-AMERICA,07/29/2020
P160026 S017
Physio-Control. Inc.07/29/2020
P980035 S632
MEDTRONIC Inc.07/29/2020
P080011 S107
CooperVision, Inc.07/28/2020
P080011 S108
CooperVision, Inc.07/28/2020
P100045 S044
St. Jude Medical07/28/2020
P130016 S042
Cochlear Americas07/28/2020
P160026 S016
Physio-Control. Inc.07/28/2020
P180046 S019
Axonics Modulation Technologie07/28/2020
P190006 S019
Axonics Modulation Technologie07/28/2020
P190031
Ventana Medical Systems, Inc.07/28/2020
P850079 S088
COOPERVISION, INC.07/28/2020
P010015 S438
MEDTRONIC Inc.07/24/2020
P010031 S703
MEDTRONIC CARDIAC RHYTHM DISEA07/24/2020
P150033 S075
MEDTRONIC Inc.07/24/2020
P170019 S019
Foundation Medicine, Inc.07/24/2020
P890003 S430
Medtronic, Inc.07/24/2020
P950018 S019
ALCON LABORATORIES07/24/2020
P980016 S742
MEDTRONIC CARDIAC RHYTHM DISEA07/24/2020
P980035 S628
MEDTRONIC Inc.07/24/2020
P990004 S041
Ferrosan Meidcal Devices A/S07/24/2020
P040002 S065
ENDOLOGIX, INC.07/23/2020
P100021 S081
Medtronic Vascular07/23/2020
P100040 S040
Medtronic Vascular07/23/2020
P180047 S003
DiaSorin, Inc.07/23/2020
P930029 S066
MEDTRONIC Inc.07/23/2020
P010015 S441
MEDTRONIC Inc.07/22/2020
P010031 S707
MEDTRONIC CARDIAC RHYTHM DISEA07/22/2020
P030036 S121
MEDTRONIC CARDIAC RHYTHM DISEA07/22/2020
P060039 S100
MEDTRONIC Inc.07/22/2020
P080006 S149
MEDTRONIC Inc.07/22/2020
P080013 S020
INTEGRA LIFESCIENCES CORPORATI07/22/2020
P090013 S306
Medtronic, Inc07/22/2020
P110035 S061
Boston Scientific Corp.07/22/2020
P110042 S139
BOSTON SCIENTIFIC CORPORATION07/22/2020
P120017 S022
MEDTRONIC Inc.07/22/2020
P130009 S110
EDWARDS LIFESCIENCES, LLC.07/22/2020
P140004 S017
Boston Scientific Neuromodulat07/22/2020
P140019 S004
CERAPEDICS, LLC07/22/2020
P140031 S107
EDWARDS LIFESCIENCES, LLC.07/22/2020
P140031 S117
EDWARDS LIFESCIENCES, LLC.07/22/2020
P150033 S076
MEDTRONIC Inc.07/22/2020
P150048 S046
EDWARDS LIFESCIENCES, LLC.07/22/2020
P830061 S182
MEDTRONIC CARDIAC RHYTHM DISEA07/22/2020
P850089 S148
MEDTRONIC CARDIAC RHYTHM DISEA07/22/2020
P890003 S432
Medtronic, Inc.07/22/2020
P900061 S159
MEDTRONIC CARDIAC RHYTHM DISEA07/22/2020
P920015 S244
MEDTRONIC Inc.07/22/2020
P930031 S068
Boston Scientific Corp.07/22/2020
P930039 S212
Medtronic, Inc.07/22/2020
P940019 S059
BOSTON SCIENTIFIC SCIMED, INC.07/22/2020
P950024 S093
MEDTRONIC Inc.07/22/2020
P960058 S150
ADVANCED BIONICS07/22/2020
P980016 S747
MEDTRONIC CARDIAC RHYTHM DISEA07/22/2020
P980033 S058
BOSTON SCIENTIFIC CORPORATION07/22/2020
P980035 S631
MEDTRONIC Inc.07/22/2020
P980050 S127
MEDTRONIC Inc.07/22/2020
P010031 S706
MEDTRONIC CARDIAC RHYTHM DISEA07/21/2020
P020011 S016
GEN-PROBE07/21/2020
P070026 S070
DEPUY ORTHOPAEDICS, INC.07/21/2020
P100033 S012
GEN-PROBE INCORPORATED07/21/2020
P100042 S031
GEN-PROBE INCORPORATED07/21/2020
P120007 S028
GEN-PROBE INCORPORATED07/21/2020
P130013 S035
Boston Scientific Corp.07/21/2020
P160023 S019
HOLOGIC, INC.07/21/2020
P160047 S012
AEGEA MEDICAL , INC07/21/2020
P170025 S016
Hologic, Inc07/21/2020
P180046 S013
Axonics Modulation Technologie07/21/2020
P190006 S014
Axonics Modulation Technologie07/21/2020
P980016 S746
MEDTRONIC CARDIAC RHYTHM DISEA07/21/2020
P100047 S168
Medtronic07/20/2020
P130008 S054
INSPIRE MEDICAL SYSTEMS07/20/2020
P140028 S062
BOSTON SCIENTIFIC CORPORATION07/20/2020
P180011 S035
Boston Scientific Corp.07/20/2020
P190018 S002
Alcon Research, Ltd.07/20/2020
P190018 S003
Alcon Research, Ltd.07/20/2020
P030053 S050
MENTOR CORP.07/17/2020
P050016 S012
CORIN U.S.A.07/17/2020
P050047 S077
Allergan07/17/2020
P080020 S038
SEIKAGAKU CORP.07/17/2020
P110033 S055
Allergan07/17/2020
P160008 S012
HeartSine Technologies, Ltd.07/17/2020
P180027 S001
MicroVention Terumo07/17/2020
P830055 S253
DEPUY, INC.07/17/2020
P940015 S046
Sanofi GENZYME CORP.07/17/2020
P980044 S053
SEIKAGAKU CORP.07/17/2020
P990071 S044
BIOSENSE WEBSTER, INC.07/17/2020
P010031 S705
MEDTRONIC CARDIAC RHYTHM DISEA07/16/2020
P030039 S025
BAXTER BIO SCIENCE07/16/2020
P050023 S147
BIOTRONIK, INC.07/16/2020
P130004 S009
OCULAR THERAPEUTIX, INC.07/16/2020
P160029 S004
PHILIPS MEDICAL SYSTEMS, INC.07/16/2020
P180028 S001
Philips Medical Systems07/16/2020
P900056 S186
Boston Scientific Corp.07/16/2020
P980016 S745
MEDTRONIC CARDIAC RHYTHM DISEA07/16/2020
N12159 S072
ETHICON, INC.07/15/2020
P040027 S079
W. L. GORE & ASSOCIATES, INC.07/15/2020
P040037 S139
W.L. GORE & ASSOCIATES,INC07/15/2020
P070026 S075
DEPUY ORTHOPAEDICS, INC.07/15/2020
P080006 S147
MEDTRONIC Inc.07/15/2020
P100047 S167
Medtronic07/15/2020
P130005 S030
CARDIOVASCULAR SYSTEMS, INC.07/15/2020
P130006 S078
W.L. GORE & ASSOCIATES,INC07/15/2020
P190018 S001
Alcon Research, Ltd.07/15/2020
P880047 S037
ETHICON, INC.07/15/2020
P100026 S081
NEUROPACE INC07/14/2020
P100026 S083
NEUROPACE INC07/14/2020
P130017 S037
Exact Sciences Corporation07/14/2020
P170035 S008
Bausch and Lomb, Inc.07/14/2020
P830055 S249
DEPUY, INC.07/14/2020
P060037 S065
ZIMMER, INC.07/13/2020
P130021 S079
MEDTRONIC COREVALVE LLC07/13/2020
P170018 S005
Physio-Control, Inc07/13/2020
P830055 S251
DEPUY, INC.07/13/2020
P000006 S054
COLOPLAST CORP.07/10/2020
P000054 S059
Medtronic Sofamor Danek USA, I07/10/2020
P000058 S078
Medtronic Sofamor Danek USA, I07/10/2020
P030031 S107
BIOSENSE WEBSTER, INC.07/10/2020
P040036 S075
BIOSENSE WEBSTER, INC.07/10/2020
P050053 S050
MEDTRONIC Inc.07/10/2020
P090013 S307
Medtronic, Inc07/10/2020
P110005 S004
IBSA INSTITUT BIOCHIMIQUE SA07/10/2020
P130014 S007
HYPERBRANCH MEDICAL TECHNOLOGY07/10/2020
P140003 S073
ABIOMED, INC.07/10/2020
P150048 S029
EDWARDS LIFESCIENCES, LLC.07/10/2020
P160054 S029
Thoratec Corporation07/10/2020
P170011 S024
Abiomed, Inc.07/10/2020
P180011 S033
Boston Scientific Corp.07/10/2020
P180046 S017
Axonics Modulation Technologie07/10/2020
P190006 S017
Axonics Modulation Technologie07/10/2020
P830061 S183
MEDTRONIC CARDIAC RHYTHM DISEA07/10/2020
P930039 S213
Medtronic, Inc.07/10/2020
P000029 S089
Palette Life Sciences07/09/2020
P020024 S062
Abbott Medical07/09/2020
P040043 S115
W. L. GORE & ASSOCIATES, INC.07/09/2020
P100014 S027
Palette Life Sciences07/09/2020
P100047 S132
Medtronic07/09/2020
P120006 S036
Endologix, Inc.07/09/2020
P160026 S018
Physio-Control. Inc.07/09/2020
P010015 S440
MEDTRONIC Inc.07/08/2020
P010031 S704
MEDTRONIC CARDIAC RHYTHM DISEA07/08/2020
P070026 S073
DEPUY ORTHOPAEDICS, INC.07/08/2020
P180032 S001
Channel Medsystems, Inc.07/08/2020
P180046 S018
Axonics Modulation Technologie07/08/2020
P190006 S018
Axonics Modulation Technologie07/08/2020
P980016 S743
MEDTRONIC CARDIAC RHYTHM DISEA07/08/2020
P980035 S629
MEDTRONIC Inc.07/08/2020
P990004 S040
Ferrosan Meidcal Devices A/S07/08/2020
P010012 S520
Boston Scientific Corp.07/07/2020
P110042 S137
BOSTON SCIENTIFIC CORPORATION07/07/2020
P160022 S017
ZOLL MEDICAL CORPORATION07/07/2020
P830055 S250
DEPUY, INC.07/07/2020
P910073 S157
BOSTON SCIENTIFIC07/07/2020
P910077 S178
BOSTON SCIENTIFIC07/07/2020

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