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
P180031 S002
Stryker Neurovascular01/18/2020
P100010 S100
Medtronic CryoCath LP01/17/2020
P160026 S013
Physio-Control. Inc.01/17/2020
P960058 S147
ADVANCED BIONICS01/17/2020
P010031 S688
MEDTRONIC CARDIAC RHYTHM DISEA01/16/2020
P130008 S049
INSPIRE MEDICAL SYSTEMS01/16/2020
P140031 S105
EDWARDS LIFESCIENCES, LLC.01/16/2020
P150026 S009
CARDIOFOCUS, INC.01/16/2020
P160047 S006
AEGEA MEDICAL , INC01/16/2020
P910056 S040
Bausch & Lomb, Inc.01/16/2020
P940015 S045
Sanofi GENZYME CORP.01/16/2020
P980016 S727
MEDTRONIC CARDIAC RHYTHM DISEA01/16/2020
P980035 S613
MEDTRONIC Inc.01/16/2020
P080012 S057
FLOWONIX MEDICAL, INC.01/15/2020
P080012 S064
FLOWONIX MEDICAL, INC.01/15/2020
P150033 S061
MEDTRONIC Inc.01/15/2020
P150036 S039
EDWARDS LIFESCIENCES, LLC.01/15/2020
P150048 S034
EDWARDS LIFESCIENCES, LLC.01/15/2020
P860057 S189
EDWARDS LIFESCIENCES, LLC.01/15/2020
P130026 S055
St. Jude Medical01/14/2020
P190006 S001
Axonics Modulation Technologie01/14/2020
P970003 S229
LivaNova USA, Inc.01/13/2020
P010032 S158
Abbott Medical01/10/2020
P030036 S116
MEDTRONIC CARDIAC RHYTHM DISEA01/10/2020
P050031 S004
PARAGON VISION SCIENCES01/10/2020
P130008 S048
INSPIRE MEDICAL SYSTEMS01/10/2020
P140009 S054
Abbott Medical01/10/2020
P150004 S034
Abbott Medical01/10/2020
P920015 S240
MEDTRONIC Inc.01/10/2020
P980050 S125
MEDTRONIC Inc.01/10/2020
P980052 S007
TMJ CONCEPTS01/10/2020
P010015 S425
MEDTRONIC Inc.01/09/2020
P010031 S687
MEDTRONIC CARDIAC RHYTHM DISEA01/09/2020
P080025 S200
MEDTRONIC NEUROMODULATION01/09/2020
P080025 S201
MEDTRONIC NEUROMODULATION01/09/2020
P090031 S009
Anika Therapeutics, Inc.01/09/2020
P100021 S079
Medtronic Vascular01/09/2020
P130030 S065
Boston Scientific Corp.01/09/2020
P140032 S045
Medtronic, Inc.01/09/2020
P140032 S046
Medtronic, Inc.01/09/2020
P150033 S064
MEDTRONIC Inc.01/09/2020
P160008 S008
HeartSine Technologies, Ltd.01/09/2020
P840001 S451
MEDTRONIC NEUROMODULATION01/09/2020
P840001 S452
MEDTRONIC NEUROMODULATION01/09/2020
P860004 S349
MEDTRONIC Inc.01/09/2020
P860004 S350
MEDTRONIC Inc.01/09/2020
P930014 S124
Alcon Research, Ltd.01/09/2020
P950020 S100
Boston Scientific Corp.01/09/2020
P960009 S366
MEDTRONIC Inc.01/09/2020
P960009 S367
MEDTRONIC Inc.01/09/2020
P970004 S305
MEDTRONIC NEUROMODULATION01/09/2020
P970004 S306
MEDTRONIC NEUROMODULATION01/09/2020
P980016 S726
MEDTRONIC CARDIAC RHYTHM DISEA01/09/2020
P980035 S612
MEDTRONIC Inc.01/09/2020
P120005 S086
DEXCOM, INC.01/08/2020
P160047 S005
AEGEA MEDICAL , INC01/08/2020
P010015 S424
MEDTRONIC Inc.01/07/2020
P010031 S686
MEDTRONIC CARDIAC RHYTHM DISEA01/07/2020
P110029 S029
Abbott Laboratories01/07/2020
P190018
Alcon Research, Ltd.01/07/2020
P980016 S725
MEDTRONIC CARDIAC RHYTHM DISEA01/07/2020
P980035 S611
MEDTRONIC Inc.01/07/2020
P030035 S179
St. Jude Medical, Inc.01/06/2020
P030054 S375
St. Jude Medical01/06/2020
P140033 S052
St. Jude Medical, Inc.01/06/2020
P140033 S053
St. Jude Medical, Inc.01/06/2020
P880086 S310
St. Jude Medical, Inc.01/06/2020
P880086 S311
St. Jude Medical, Inc.01/06/2020
P910023 S424
St. Jude Medical01/06/2020
P010030 S131
ZOLL MANUFACTURING CORPORATION01/03/2020
P110010 S163
Boston Scientific Corp.01/03/2020
P110010 S164
Boston Scientific Corp.01/03/2020
P010029 S029
FERRING PHARMACEUTICALS, INC.01/02/2020
P090015 S010
Leica Biosystems01/02/2020
P140009 S039
Abbott Medical01/02/2020
P180038
DiaSorin Inc.01/02/2020
P830055 S242
DEPUY, INC.01/02/2020
P130028 S025
Nuvectra Corporation12/31/2019
N970012 S164
Boston Scientific Corp.12/30/2019
P000053 S105
Boston Scientific Corp.12/30/2019
P080004 S029
HOYA SURGICAL OPTICS, INC.12/30/2019
P160054 S024
Thoratec Corporation12/30/2019
P930014 S120
Alcon Research, Ltd.12/30/2019
P140020 S019
MYRIAD GENETIC LABORATORIES12/27/2019
P050037 S101
MERZ NORTH AMERICA, INC12/26/2019
P050052 S118
MERZ NORTH AMERICA, INC12/26/2019
P840001 S447
MEDTRONIC NEUROMODULATION12/26/2019

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