FDA 501(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
P010012 S512
Boston Scientific Corp.12/06/2019
P010033 S046
QIAGEN12/06/2019
P040027 S075
W. L. GORE & ASSOCIATES, INC.12/06/2019
P100006 S011
BIOMIMETIC THERAPEUTICS,LLC12/06/2019
P140033 S051
St. Jude Medical, Inc.12/06/2019
P160014 S012
CELONOVA BIOSCIENCES, INC.12/06/2019
P170038
Abbott12/06/2019
P180002 S014
Pulmonx Corporation12/06/2019
P180029 S003
Boston Scientific Corporation12/06/2019
P880086 S309
St. Jude Medical, Inc.12/06/2019
P950009 S023
BD DIAGNOSTICS12/06/2019
P010030 S127
ZOLL MANUFACTURING CORPORATION12/05/2019
P030017 S332
Boston Scientific Corp.12/05/2019
P050010 S022
Centinel Spine, LLC12/05/2019
P140002 S020
TERUMO MEDICAL CORPORATION12/05/2019
N970003 S246
Boston Scientific Corp.12/04/2019
N970012 S170
Boston Scientific Corp.12/04/2019
P000015 S038
Cochlear Americas12/04/2019
P000053 S109
Boston Scientific Corp.12/04/2019
P000054 S058
Medtronic Sofamor Danek USA, I12/04/2019
P000058 S077
Medtronic Sofamor Danek USA, I12/04/2019
P010012 S513
Boston Scientific Corp.12/04/2019
P030005 S192
GUIDANT CORP.12/04/2019
P040021 S042
St. Jude Medical, Inc.12/04/2019
P050053 S049
MEDTRONIC Inc.12/04/2019
P060027 S100
MicroPort CRM USA Inc.12/04/2019
P080004 S026
HOYA SURGICAL OPTICS, INC.12/04/2019
P080004 S027
HOYA SURGICAL OPTICS, INC.12/04/2019
P090013 S302
Medtronic, Inc12/04/2019
P100029 S042
St. Jude Medical, Inc.12/04/2019
P110010 S173
Boston Scientific Corp.12/04/2019
P130016 S038
Cochlear Americas12/04/2019
P140028 S047
BOSTON SCIENTIFIC CORPORATION12/04/2019
P140028 S048
BOSTON SCIENTIFIC CORPORATION12/04/2019
P140028 S049
BOSTON SCIENTIFIC CORPORATION12/04/2019
P140030 S011
BIOTRONIK, INC.12/04/2019
P150003 S056
BOSTON SCIENTIFIC CORPORATION12/04/2019
P150012 S087
BOSTONSCIENTIFIC12/04/2019
P150031 S027
Boston Scientific Corp.12/04/2019
P160003 S009
BIOTRONIK, INC.12/04/2019
P160025 S009
BIOTRONIK, INC.12/04/2019
P170030 S005
Biotronik, Inc12/04/2019
P180011 S017
Boston Scientific Corp.12/04/2019
P180011 S018
Boston Scientific Corp.12/04/2019
P180011 S019
Boston Scientific Corp.12/04/2019
P830055 S240
DEPUY, INC.12/04/2019
P880047 S033
ETHICON, INC.12/04/2019
P920015 S237
MEDTRONIC Inc.12/04/2019
P930039 S205
Medtronic, Inc.12/04/2019
P960040 S445
BOSTON SCIENTIFIC12/04/2019
P970051 S187
Cochlear Americas12/04/2019
P980035 S607
MEDTRONIC Inc.12/04/2019
P990074 S043
Allergan12/04/2019
N12159 S067
ETHICON, INC.12/03/2019
N18286 S033
PFIZER, INC.12/03/2019
P010015 S422
MEDTRONIC Inc.12/03/2019
P010031 S685
MEDTRONIC CARDIAC RHYTHM DISEA12/03/2019
P030036 S115
MEDTRONIC CARDIAC RHYTHM DISEA12/03/2019
P050047 S074
Allergan12/03/2019
P050051 S036
ABBOTT LABORATORIES INC12/03/2019
P060039 S098
MEDTRONIC Inc.12/03/2019
P080006 S143
MEDTRONIC Inc.12/03/2019
P090013 S303
Medtronic, Inc12/03/2019
P110033 S051
Allergan12/03/2019
P120017 S020
MEDTRONIC Inc.12/03/2019
P150033 S063
MEDTRONIC Inc.12/03/2019
P160021 S023
W. L. Gore & Associates, Inc.12/03/2019
P170019 S006
Foundation Medicine, Inc.12/03/2019
P830055 S238
DEPUY, INC.12/03/2019
P830055 S241
DEPUY, INC.12/03/2019
P830061 S177
MEDTRONIC CARDIAC RHYTHM DISEA12/03/2019
P850022 S030
EBI, LLC12/03/2019
P850089 S145
MEDTRONIC CARDIAC RHYTHM DISEA12/03/2019
P890003 S422
Medtronic, Inc.12/03/2019
P900061 S156
MEDTRONIC CARDIAC RHYTHM DISEA12/03/2019
P920015 S239
MEDTRONIC Inc.12/03/2019
P930039 S207
Medtronic, Inc.12/03/2019
P950024 S090
MEDTRONIC Inc.12/03/2019
P980016 S724
MEDTRONIC CARDIAC RHYTHM DISEA12/03/2019
P980035 S609
MEDTRONIC Inc.12/03/2019
P980050 S124
MEDTRONIC Inc.12/03/2019
P110014 S010
DUNE MEDICAL DEVICES INC12/02/2019
P140004 S016
Boston Scientific Neuromodulat12/02/2019
P180013 S003
Boston Scientific Corporation12/02/2019
P000054 S057
Medtronic Sofamor Danek USA, I11/29/2019
P000058 S076
Medtronic Sofamor Danek USA, I11/29/2019
P050053 S048
MEDTRONIC Inc.11/29/2019
P070026 S059
DEPUY ORTHOPAEDICS, INC.11/29/2019
P080004 S025
HOYA SURGICAL OPTICS, INC.11/29/2019
P160036 S001
DT MedTech LLC11/29/2019
P140003 S064
ABIOMED, INC.11/28/2019
N970003 S245
Boston Scientific Corp.11/27/2019
N970012 S168
Boston Scientific Corp.11/27/2019
N970012 S169
Boston Scientific Corp.11/27/2019
P000053 S108
Boston Scientific Corp.11/27/2019
P010019 S072
Alcon Laboratories, Inc.11/27/2019
P030005 S191
GUIDANT CORP.11/27/2019
P090013 S304
Medtronic, Inc11/27/2019
P150012 S086
BOSTONSCIENTIFIC11/27/2019
P830061 S178
MEDTRONIC CARDIAC RHYTHM DISEA11/27/2019
P930039 S208
Medtronic, Inc.11/27/2019
N12159 S052
ETHICON, INC.11/26/2019
P030011 S074
SYNCARDIA SYSTEMS, LLC11/26/2019
P080025 S194
MEDTRONIC NEUROMODULATION11/26/2019
P110010 S172
Boston Scientific Corp.11/26/2019
P130030 S063
Boston Scientific Corp.11/26/2019
P140031 S101
EDWARDS LIFESCIENCES, LLC.11/26/2019
P150003 S057
BOSTON SCIENTIFIC CORPORATION11/26/2019
P150017 S014
Cartiva, Inc11/26/2019
P150036 S047
EDWARDS LIFESCIENCES, LLC.11/26/2019
P150048 S042
EDWARDS LIFESCIENCES, LLC.11/26/2019
P160029 S002
PHILIPS MEDICAL SYSTEMS, INC.11/26/2019
P170003 S014
LUTONIX11/26/2019
P180047
DiaSorin, Inc.11/26/2019
P860057 S195
EDWARDS LIFESCIENCES, LLC.11/26/2019
P910077 S175
BOSTON SCIENTIFIC11/26/2019
P950037 S202
BIOTRONIK, INC.11/26/2019
P970004 S299
MEDTRONIC NEUROMODULATION11/26/2019
P110015 S006
ADVANCED BREATH DIAGNOSTICS11/25/2019
P140003 S063
ABIOMED, INC.11/25/2019
P160026 S011
Physio-Control. Inc.11/25/2019
P160048 S012
Senseonics, Incorporated11/25/2019
P170011 S019
Abiomed, Inc.11/25/2019
P190016
Tusker Medical, Inc.11/25/2019
P130009 S104
EDWARDS LIFESCIENCES, LLC.11/24/2019
P140031 S100
EDWARDS LIFESCIENCES, LLC.11/24/2019
P150036 S045
EDWARDS LIFESCIENCES, LLC.11/24/2019
P150048 S041
EDWARDS LIFESCIENCES, LLC.11/24/2019
P860057 S194
EDWARDS LIFESCIENCES, LLC.11/24/2019
P120010 S134
MEDTRONIC Inc.11/22/2019
P130022 S022
NEVRO CORPORATION11/22/2019
P150001 S074
MEDTRONIC MINIMED11/22/2019
P150019 S059
MEDTRONIC MINIMED11/22/2019
P150029 S032
MEDTRONIC MINIMED11/22/2019
P160007 S026
MEDTRONIC MINIMED11/22/2019
P160017 S072
MEDTRONIC MINIMED, INC.11/22/2019
P160037 S003
BECTON, DICKINSON AND COMPANY11/22/2019
P160055 S008
RxSight, Inc.11/22/2019
P850064 S041
BUNNELL, INC.11/22/2019
P980040 S110
Johnson & Johnson Surgical Vis11/22/2019
P010003 S033
CRYOLIFE, INC.11/21/2019
P060038 S033
LivaNova Canada Corp.11/21/2019
P070004 S028
SIENTRA, INC11/21/2019
P150033 S060
MEDTRONIC Inc.11/21/2019
P180002 S012
Pulmonx Corporation11/21/2019
P180002 S013
Pulmonx Corporation11/21/2019
P180029 S017
Boston Scientific Corporation11/21/2019
P190008
Medtronic Vascular Inc.11/21/2019
P830055 S235
DEPUY, INC.11/21/2019
P900056 S180
Boston Scientific Corp.11/21/2019
P060040 S074
THORATEC CORP.11/20/2019
P110023 S028
MEDTRONIC VASCULAR INC11/20/2019
P140003 S062
ABIOMED, INC.11/20/2019
P150033 S059
MEDTRONIC Inc.11/20/2019
P160054 S022
Thoratec Corporation11/20/2019
P170011 S018
Abiomed, Inc.11/20/2019
N12159 S066
ETHICON, INC.11/19/2019
P010030 S128
ZOLL MANUFACTURING CORPORATION11/19/2019
P010032 S155
Abbott Medical11/19/2019
P030053 S054
MENTOR CORP.11/19/2019
P050006 S081
W.L. GORE & ASSOCIATES,INC11/19/2019
P050038 S034
C.R. Bard, Inc.11/19/2019
P060028 S034
MENTOR WORLDWIDE LLC11/19/2019
P100027 S031
VENTANA MEDICAL SYSTEMS, INC.11/19/2019
P140009 S051
Abbott Medical11/19/2019
P140025 S011
VENTANA MEDICAL SYSTEMS, INC.11/19/2019
P150004 S032
Abbott Medical11/19/2019
P160002 S010
VENTANA MEDICAL SYSTEMS, INC.11/19/2019
P160008 S007
HeartSine Technologies, Ltd.11/19/2019
P160046 S006
Ventana Medical Systems, Inc.11/19/2019
P170008 S019
Medinol, Ltd.11/19/2019
P990075 S046
MENTOR WORLDWIDE LLC11/19/2019
P990081 S041
VENTANA MEDICAL SYSTEMS, INC.11/19/2019
P150036 S044
EDWARDS LIFESCIENCES, LLC.11/18/2019
P150048 S040
EDWARDS LIFESCIENCES, LLC.11/18/2019
P860057 S193
EDWARDS LIFESCIENCES, LLC.11/18/2019
P010012 S511
Boston Scientific Corp.11/15/2019
P120010 S136
MEDTRONIC Inc.11/15/2019
P150001 S077
MEDTRONIC MINIMED11/15/2019
P150019 S060
MEDTRONIC MINIMED11/15/2019
P150029 S033
MEDTRONIC MINIMED11/15/2019
P160007 S028
MEDTRONIC MINIMED11/15/2019
P160017 S075
MEDTRONIC MINIMED, INC.11/15/2019
P180035
CooperVision, Inc.11/15/2019
P960040 S444
BOSTON SCIENTIFIC11/15/2019
P150036 S046
EDWARDS LIFESCIENCES, LLC.11/14/2019
P830055 S237
DEPUY, INC.11/14/2019
P850079 S085
COOPERVISION, INC.11/14/2019
P890023 S039
THE COOPER COMPANIES11/14/2019
P910023 S421
St. Jude Medical11/14/2019
P000008 S047
ReShape Lifesciences, Inc.11/13/2019
P110002 S022
LDR Spine USA11/13/2019
P110009 S022
LDR SPINE USA INC.11/13/2019
P130021 S067
MEDTRONIC COREVALVE LLC11/13/2019
P160045 S018
LIFE TECHNOLOGIES CORPORATION11/13/2019
P180002 S010
Pulmonx Corporation11/13/2019
P180046
Axonics Modulation Technologie11/13/2019
P980037 S074
Boston Scientific Corp.11/13/2019

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