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
P100009 S043
ABBOTT VASCULAR INC.08/01/2021
P020056 S057
Allergan07/30/2021
P110019 S117
ABBOTT VASCULAR07/30/2021
N12159 S080
ETHICON, INC.07/30/2021
P170019 S026
Foundation Medicine, Inc.07/30/2021
P180036 S007
Impulse Dynamics (USA), Inc.07/30/2021
P200011
Pillar Biosciences07/30/2021
P950022 S140
Abbott Medical07/29/2021
P990046 S059
MEDTRONIC ATS MEDICAL, INC.07/29/2021
P160038 S019
Illumina, Inc.07/29/2021
P960009 S403
MEDTRONIC Inc.07/29/2021
P980040 S141
Johnson & Johnson Surgical Vis07/28/2021
P170030 S018
Biotronik, Inc07/28/2021
P910018 S031
KANEKA PHARMA AMERICA CORP.07/28/2021
P010032 S179
Abbott Medical07/28/2021
P150028 S005
NUMED, INC.07/28/2021
P160039 S006
RESPICARDIA07/28/2021
P100018 S033
Micro Therapeutics, Inc. d/b/a07/27/2021
P160043 S050
MEDTRONIC VASCULAR07/27/2021
P100030 S015
Baxter Healthcare Corporation07/27/2021
P120021 S021
Abbott Medical07/27/2021
P050018 S031
SPECTRANETICS CORP.07/27/2021
P040040 S044
Abbott Medical07/27/2021
P020024 S065
Abbott Medical07/27/2021
P000039 S074
Abbott Medical07/27/2021
P200037
Kestra Medical Technologies, I07/27/2021
P040046 S031
Allergan07/26/2021
P040029 S020
Euclid Systems Corporation07/26/2021
P180032 S008
Channel Medsystems, Inc.07/26/2021
P180035 S003
CooperVision, Inc.07/26/2021
P010032 S172
Abbott Medical07/26/2021
P140009 S067
Abbott Medical07/26/2021
P070006 S017
OXFORD IMMUNOTEC,LTD.07/26/2021
P010003 S038
CRYOLIFE, INC.07/23/2021
P150048 S055
EDWARDS LIFESCIENCES, LLC.07/23/2021
P960040 S467
BOSTON SCIENTIFIC07/23/2021
P030053 S064
MENTOR CORP.07/22/2021
P180032 S007
Channel Medsystems, Inc.07/22/2021
P140031 S129
EDWARDS LIFESCIENCES, LLC.07/22/2021
P100047 S185
Medtronic07/22/2021
P010031 S752
MEDTRONIC CARDIAC RHYTHM DISEA07/22/2021
P060028 S043
MENTOR WORLDWIDE LLC07/22/2021
P200039 S003
Shockwave Medical, Inc.07/22/2021
P150038 S013
InSightec07/22/2021
P050047 S082
Allergan07/21/2021
P960009 S402
MEDTRONIC Inc.07/21/2021
P990075 S052
MENTOR WORLDWIDE LLC07/21/2021
P080025 S230
MEDTRONIC NEUROMODULATION07/21/2021
P970004 S335
MEDTRONIC NEUROMODULATION07/21/2021
P840001 S492
MEDTRONIC NEUROMODULATION07/21/2021
P190008 S016
Medtronic Vascular Inc.07/21/2021
P050023 S158
BIOTRONIK, INC.07/21/2021
P000009 S093
BIOTRONIK, INC.07/21/2021
P150005 S065
Boston Scientific Corp.07/21/2021
P860004 S376
MEDTRONIC Inc.07/21/2021
P200022 S007
NuVasive, Inc.07/21/2021
P980023 S106
BIOTRONIK, INC.07/21/2021
P070008 S127
BIOTRONIK, INC.07/21/2021
P140032 S073
Medtronic, Inc.07/21/2021
P950037 S226
BIOTRONIK, INC.07/21/2021
P170019 S022
Foundation Medicine, Inc.07/21/2021
P910056 S046
Bausch & Lomb, Inc.07/21/2021
P110033 S061
Allergan07/21/2021
P050047 S080
Allergan07/21/2021
P110033 S058
Allergan07/21/2021
P150005 S064
Boston Scientific Corp.07/20/2021
P070026 S083
DEPUY ORTHOPAEDICS, INC.07/20/2021
P020056 S056
Allergan07/20/2021
P990074 S047
Allergan07/20/2021
P130021 S101
MEDTRONIC COREVALVE LLC07/19/2021
P060037 S072
ZIMMER, INC.07/19/2021
P030016 S041
STAAR Surgical Company07/19/2021
P990013 S041
STARR SURGICAL CO.07/19/2021
P200046 S005
Medtronic, Inc.07/19/2021
P100018 S032
Micro Therapeutics, Inc. d/b/a07/19/2021
P830061 S196
MEDTRONIC CARDIAC RHYTHM DISEA07/16/2021
P130022 S039
Nevro Corporation07/16/2021
P180027 S003
MicroVention, Inc.07/16/2021
P170013 S006
MicroVention, Inc.07/16/2021
P170032 S007
MicroVention, Inc.07/16/2021
P830063 S018
BAXTER INTERNATIONAL, INC.07/16/2021
P150033 S116
MEDTRONIC Inc.07/16/2021
P190032 S001
Foundation Medicine Inc.07/15/2021
P080025 S231
MEDTRONIC NEUROMODULATION07/15/2021
P970004 S336
MEDTRONIC NEUROMODULATION07/15/2021
P150004 S048
Abbott Medical07/15/2021
P030039 S026
BAXTER BIO SCIENCE07/15/2021
P140009 S070
Abbott Medical07/15/2021
P010032 S177
Abbott Medical07/15/2021
P840001 S495
MEDTRONIC NEUROMODULATION07/15/2021
P980016 S787
MEDTRONIC CARDIAC RHYTHM DISEA07/14/2021
P150012 S113
BOSTONSCIENTIFIC07/14/2021
P040020 S099
Alcon Research, Ltd.07/14/2021
P930014 S137
ALCON LABORATORIES, INC.07/14/2021
P150005 S063
Boston Scientific Corp.07/14/2021
P980035 S687
MEDTRONIC Inc.07/14/2021
P010031 S751
MEDTRONIC CARDIAC RHYTHM DISEA07/14/2021
P010015 S478
MEDTRONIC Inc.07/14/2021
P150033 S115
MEDTRONIC Inc.07/14/2021
P200017
Siemens Healthcare Diagnostics07/14/2021
P170030 S017
Biotronik, Inc07/13/2021
P160003 S014
BIOTRONIK, INC.07/13/2021
P990037 S035
Vascular Solutions, Inc.07/13/2021
P810031 S072
Johnson & Johnson Surgical Vis07/13/2021
P140003 S081
ABIOMED, INC.07/13/2021
P140003 S083
ABIOMED, INC.07/13/2021
P140003 S082
ABIOMED, INC.07/13/2021
P170024 S009
Stryker Neurovascular07/12/2021
P180035 S004
CooperVision, Inc.07/12/2021
P030017 S344
Boston Scientific Corp.07/12/2021
P170011 S033
Abiomed, Inc.07/12/2021
P130021 S100
MEDTRONIC COREVALVE LLC07/12/2021
P040036 S083
BIOSENSE WEBSTER, INC.07/09/2021
P030031 S121
BIOSENSE WEBSTER, INC.07/09/2021
P990071 S050
BIOSENSE WEBSTER, INC.07/09/2021
P950005 S081
Biosense Webster, Inc07/09/2021
P200026 S002
Medtronic Vascular, Inc.07/09/2021
P990025 S066
BIOSENSE WEBSTER, INC.07/09/2021
P010068 S066
BIOSENSE WEBSTER, INC.07/09/2021
P900033 S096
Integra LifeSciences Corp.07/09/2021
P140016 S003
COOK MEDICAL INCORPORATED07/09/2021
P170011 S031
Abiomed, Inc.07/09/2021
P140003 S078
ABIOMED, INC.07/09/2021
P150033 S114
MEDTRONIC Inc.07/09/2021
P000053 S121
Boston Scientific Corp.07/08/2021
P100016 S008
Carl Zeiss Meditec Production07/08/2021
P840001 S491
MEDTRONIC NEUROMODULATION07/08/2021
P150033 S113
MEDTRONIC Inc.07/08/2021
N970012 S188
Boston Scientific Corp.07/08/2021
P810025 S042
Bausch & Lomb, Inc.07/08/2021
P160026 S015
Physio-Control. Inc.07/08/2021
P030008 S034
Alcon Laboratories, Inc.07/08/2021
P020050 S038
Alcon Laboratories, Inc.07/08/2021
N18286 S039
PFIZER, INC.07/08/2021
P160012 S003
Physio-Control. Inc.07/08/2021
P980035 S686
MEDTRONIC Inc.07/07/2021
P830055 S268
DEPUY, INC.07/07/2021
P140033 S069
Abbott Medical07/07/2021
P950022 S139
Abbott Medical07/07/2021
P960013 S119
Abbott Medical07/07/2021
P960030 S075
Abbott Medical07/07/2021
P200046 S004
Medtronic, Inc.07/07/2021
P030035 S187
Abbott Medical07/07/2021
P880086 S320
Abbott Medical07/07/2021
P030054 S393
Abbott Medical07/07/2021
P160017 S092
MEDTRONIC MINIMED, INC.07/07/2021
P070026 S082
DEPUY ORTHOPAEDICS, INC.07/07/2021
P150001 S091
MEDTRONIC MINIMED07/07/2021
P120022 S022
QIAGEN GmbH07/07/2021
P100034 S026
Novocure GmbH07/07/2021
P970013 S088
Abbott Medical07/07/2021
P900056 S193
Boston Scientific Corp.07/06/2021
P050038 S037
Davol, Inc.07/06/2021

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