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
P020056 S053
Allergan04/10/2021
P010012 S535
Boston Scientific Corp.04/09/2021
P030035 S185
St. Jude Medical, Inc.04/09/2021
P030054 S391
St. Jude Medical04/09/2021
P080025 S223
MEDTRONIC NEUROMODULATION04/09/2021
P080025 S227
MEDTRONIC NEUROMODULATION04/09/2021
P100044 S048
INTERSECT ENT04/09/2021
P130008 S064
INSPIRE MEDICAL SYSTEMS04/09/2021
P140033 S066
St. Jude Medical, Inc.04/09/2021
P200039 S001
Shockwave Medical, Inc.04/09/2021
P880086 S318
St. Jude Medical, Inc.04/09/2021
P910023 S436
St. Jude Medical04/09/2021
P950022 S138
St. Jude Medical, Inc.04/09/2021
P960013 S117
St Jude Medical04/09/2021
P960030 S074
St. Jude Medical04/09/2021
P970004 S328
MEDTRONIC NEUROMODULATION04/09/2021
P970004 S332
MEDTRONIC NEUROMODULATION04/09/2021
P970013 S086
St. Jude Medical, Inc.04/09/2021
P010031 S740
MEDTRONIC CARDIAC RHYTHM DISEA04/08/2021
P020025 S130
BOSTON SCIENTIFIC04/08/2021
P040002 S067
Endologix, LLC04/08/2021
P040043 S125
W. L. GORE & ASSOCIATES, INC.04/08/2021
P170035 S012
Bausch and Lomb, Inc.04/08/2021
P980016 S778
MEDTRONIC CARDIAC RHYTHM DISEA04/08/2021
P010068 S062
BIOSENSE WEBSTER, INC.04/07/2021
P030031 S114
BIOSENSE WEBSTER, INC.04/07/2021
P030031 S115
BIOSENSE WEBSTER, INC.04/07/2021
P040036 S079
BIOSENSE WEBSTER, INC.04/07/2021
P110035 S066
Boston Scientific Corp.04/07/2021
P170008 S034
Medinol, Ltd.04/07/2021
P810025 S041
Bausch & Lomb, Inc.04/07/2021
P950005 S077
Biosense Webster, Inc04/07/2021
P990025 S062
BIOSENSE WEBSTER, INC.04/07/2021
P050053 S056
MEDTRONIC Inc.04/06/2021
P080011 S124
CooperVision, Inc.04/06/2021
P080025 S226
MEDTRONIC NEUROMODULATION04/06/2021
P100045 S050
St. Jude Medical04/06/2021
P150026 S012
CARDIOFOCUS, INC.04/06/2021
P180028 S005
Philips Medical Systems04/06/2021
P200046 S001
Medtronic, Inc.04/06/2021
P840001 S485
MEDTRONIC NEUROMODULATION04/06/2021
P960009 S399
MEDTRONIC Inc.04/06/2021
P970004 S331
MEDTRONIC NEUROMODULATION04/06/2021
P000054 S065
Medtronic Sofamor Danek USA, I04/05/2021
P000058 S084
Medtronic Sofamor Danek USA, I04/05/2021
N970003 S261
Boston Scientific Corp.04/02/2021
P010012 S533
Boston Scientific Corp.04/02/2021
P030005 S207
GUIDANT CORP.04/02/2021
P050046 S031
GUIDANT CORP.04/02/2021
P110042 S153
BOSTON SCIENTIFIC CORPORATION04/02/2021
P110042 S155
BOSTON SCIENTIFIC CORPORATION04/02/2021
P150012 S107
BOSTONSCIENTIFIC04/02/2021
P150012 S108
BOSTONSCIENTIFIC04/02/2021
P150033 S103
MEDTRONIC Inc.04/02/2021
P830026 S083
BOSTON SCIENTIFIC04/02/2021
P830060 S085
BOSTON SCIENTIFIC04/02/2021
P840068 S055
BOSTON SCIENTIFIC04/02/2021
P890061 S024
BOSTON SCIENTIFIC04/02/2021
P910073 S160
BOSTON SCIENTIFIC04/02/2021
P910077 S183
BOSTON SCIENTIFIC04/02/2021
P930035 S031
BOSTON SCIENTIFIC04/02/2021
P940031 S079
BOSTON SCIENTIFIC04/02/2021
P950001 S029
BOSTON SCIENTIFIC04/02/2021
P960006 S051
BOSTON SCIENTIFIC04/02/2021
P960040 S462
BOSTON SCIENTIFIC04/02/2021
N12159 S079
ETHICON, INC.04/01/2021
P010015 S463
MEDTRONIC Inc.04/01/2021
P010031 S728
MEDTRONIC CARDIAC RHYTHM DISEA04/01/2021
P020036 S044
CORDIS CORP.04/01/2021
P030047 S041
CORDIS CORP.04/01/2021
P030047 S042
CORDIS CORP.04/01/2021
P120002 S019
CORDIS CORP.04/01/2021
P140032 S068
Medtronic, Inc.04/01/2021
P160055 S019
RxSight, Inc.04/01/2021
P190019 S009
Boston Scientific Corporation04/01/2021
P200022 S003
Simplify Medical, Inc.04/01/2021
P860004 S371
MEDTRONIC Inc.04/01/2021
P880047 S039
ETHICON, INC.04/01/2021
P950034 S052
Baxter Healthcare Corporation04/01/2021
P950037 S219
BIOTRONIK, INC.04/01/2021
N12159 S078
ETHICON, INC.03/31/2021
P080025 S225
MEDTRONIC NEUROMODULATION03/31/2021
P110008 S013
Surgalign Spine Technologies,03/31/2021
P140031 S128
EDWARDS LIFESCIENCES, LLC.03/31/2021
P160021 S031
W. L. Gore & Associates, Inc.03/31/2021
P170008 S033
Medinol, Ltd.03/31/2021
P180001 S002
WILLIAM COOK EUROPE APS03/31/2021
P860004 S370
MEDTRONIC Inc.03/31/2021
P960009 S398
MEDTRONIC Inc.03/31/2021
P970004 S330
MEDTRONIC NEUROMODULATION03/31/2021
P010013 S083
HOLOGIC, INC.03/30/2021
P040029 S017
Euclid Systems Corporation03/30/2021
P100047 S176
Medtronic03/30/2021
P140026 S017
SILK ROAD MEDICAL, INC03/30/2021
P180029 S030
Boston Scientific Corporation03/30/2021
P170027 S004
TherOx, Inc.03/29/2021
P170032 S001
MicroVention, Inc.03/29/2021
P190024 S004
Ventana Medical Systems, Inc.03/29/2021
P830061 S194
MEDTRONIC CARDIAC RHYTHM DISEA03/29/2021
P920015 S254
MEDTRONIC Inc.03/29/2021
P930039 S224
Medtronic, Inc.03/29/2021
P950009 S024
BD DIAGNOSTICS03/29/2021
P980035 S680
MEDTRONIC Inc.03/29/2021
P030031 S109
BIOSENSE WEBSTER, INC.03/26/2021
P060011 S025
RAYNER INTRAOCULAR LENSES LTD.03/26/2021
P150033 S099
MEDTRONIC Inc.03/26/2021
P160022 S027
ZOLL MEDICAL CORPORATION03/26/2021
P170027 S003
TherOx, Inc.03/26/2021
P180035 S007
CooperVision, Inc.03/26/2021
P180035 S008
CooperVision, Inc.03/26/2021
P200046
Medtronic, Inc.03/26/2021
P970051 S204
Cochlear Americas03/26/2021
P010031 S734
MEDTRONIC CARDIAC RHYTHM DISEA03/25/2021
P020004 S180
W.L. GORE & ASSOCIATES,INC03/25/2021
P040043 S124
W. L. GORE & ASSOCIATES, INC.03/25/2021
P080006 S160
MEDTRONIC Inc.03/25/2021
P130017 S048
Exact Sciences Corporation03/25/2021
P140032 S067
Medtronic, Inc.03/25/2021
P160021 S030
W. L. Gore & Associates, Inc.03/25/2021
P180046 S034
Axonics Modulation Technologie03/25/2021
P190006 S034
Axonics Modulation Technologie03/25/2021
P860004 S369
MEDTRONIC Inc.03/25/2021
P980016 S772
MEDTRONIC CARDIAC RHYTHM DISEA03/25/2021
P980035 S674
MEDTRONIC Inc.03/25/2021
P020047 S074
ABBOTT VASCULAR03/24/2021
P040014 S043
IRVINE BIOMEDICAL, INC.03/24/2021
P040042 S049
IRVINE BIOMEDICAL,INC.(IBI)03/24/2021
P060019 S051
IRVINE BIOMEDICAL, INC.03/24/2021
P070015 S148
ABBOTT VASCULAR INC.03/24/2021
P110010 S190
Boston Scientific Corp.03/24/2021
P110016 S074
St. Jude Medical, Inc. (Irvine03/24/2021
P110019 S116
ABBOTT VASCULAR03/24/2021
P130013 S038
Boston Scientific Corp.03/24/2021
P130021 S089
MEDTRONIC COREVALVE LLC03/24/2021
P130030 S072
Boston Scientific Corp.03/24/2021
P150003 S072
BOSTON SCIENTIFIC CORPORATION03/24/2021
P080007 S024
BARD PERIPHERAL VASCULAR, INC.03/23/2021
P130020 S004
GE Healthcare03/23/2021
P130029 S009
BARD PERIPHERAL VASCULAR, INC.03/23/2021
P150048 S052
EDWARDS LIFESCIENCES, LLC.03/23/2021
P160054 S035
Thoratec Corporation03/23/2021
P200025
Bausch Health03/23/2021
P980040 S132
Johnson & Johnson Surgical Vis03/23/2021
P070006 S016
OXFORD IMMUNOTEC,LTD.03/22/2021
P140018 S022
MEDTRONIC VASCULAR INC03/22/2021
P060040 S079
THORATEC CORP.03/21/2021
P160054 S034
Thoratec Corporation03/21/2021
P130009 S113
EDWARDS LIFESCIENCES, LLC.03/19/2021
P140031 S127
EDWARDS LIFESCIENCES, LLC.03/19/2021
P150003 S071
BOSTON SCIENTIFIC CORPORATION03/19/2021
P160026 S024
Physio-Control. Inc.03/19/2021
P160055 S018
RxSight, Inc.03/19/2021
P170002 S013
TEOXANE S.A.03/19/2021
P200015 S008
Edwards Lifesciences, LLC03/19/2021
P030004 S026
EV3 NEUROVASCULAR03/18/2021
P030054 S390
St. Jude Medical03/18/2021
P160015 S011
ZOLL MEDICAL CORPORATION03/18/2021
P160022 S026
ZOLL MEDICAL CORPORATION03/18/2021
P960030 S073
St. Jude Medical03/18/2021
P020045 S094
Medtronic CryoCath LP03/17/2021
P130017 S047
Exact Sciences Corporation03/17/2021
P150011 S022
LivaNova Canada Corp.03/17/2021
P160055 S014
RxSight, Inc.03/17/2021
P200029
Boston Scientific Corporation03/17/2021
P810002 S110
St. Jude Medical, Inc.03/17/2021
N970012 S185
Boston Scientific Corp.03/16/2021
P010031 S739
MEDTRONIC CARDIAC RHYTHM DISEA03/16/2021
P110015 S007
ADVANCED BREATH DIAGNOSTICS03/16/2021
P150033 S097
MEDTRONIC Inc.03/16/2021
P180034 S004
Philips Image Guided Therapy C03/16/2021
P180046 S033
Axonics Modulation Technologie03/16/2021
P190006 S033
Axonics Modulation Technologie03/16/2021
P980016 S777
MEDTRONIC CARDIAC RHYTHM DISEA03/16/2021
P050010 S023
Centinel Spine, LLC03/15/2021
P050050 S017
STRYKER CORPORATION03/15/2021
P110005 S008
IBSA INSTITUT BIOCHIMIQUE SA03/15/2021
P190018 S009
Alcon Research, Ltd.03/15/2021
P190019 S007
Boston Scientific Corporation03/15/2021

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