PMA Number | Suppl. Type | Device Name | Applicant | Decision Date |
---|
PMA Number | Suppl. Type | Device Name | Applicant | Decision Date |
---|---|---|---|---|
P990081
S057 |
30-Day Notice | PATHWAY Anti-her-2/neu (4B5) Rabbit Monoclonal Primary Antibody |
VENTANA MEDICAL SYSTEMS, INC. |
06/20/2025 |
P980035
S814 |
30-Day Notice | Adapta, Versa, Sensia IPG | MEDTRONIC Inc. | 06/20/2025 |
P930039
S271 |
30-Day Notice | CapSureFix Novus Lead | Medtronic, Inc. | 06/20/2025 |
P890003
S478 |
30-Day Notice | 2292 Analyzer Cable | Medtronic, Inc. | 06/20/2025 |
P830061
S231 |
30-Day Notice | CapSure Sense Lead | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
06/20/2025 |
P240037
S002 |
30-Day Notice | VENTANA MET (SP44) RxDx Assay | Ventana Medical Systems Inc (Roche Tissue Diagnostics) |
06/20/2025 |
P230040
S012 |
Real-Time Process | Cordella Pulmonary Artery Sensor System (CorPASS) |
Endotronix, Inc. | 06/20/2025 |
P230018
S001 |
30-Day Notice | VENTANA CLDN18 (43-14A) RxDx Assay | Ventana Medical Systems Inc. |
06/20/2025 |
P220013
S019 |
Real-Time Process | TactiFlex Ablation Catheter, Sensor Enabled |
Abbott Medical | 06/20/2025 |
P220006
S007 |
30-Day Notice | VENTANA FOLR1 (FOLR-2.1) RxDx Assay | Ventana Medical Systems Inc. |
06/20/2025 |
P200019
S012 |
30-Day Notice | VENTANA MMR RxDx Panel | Ventana Medical Systems | 06/20/2025 |
P190021
S009 |
Normal 180 Day Track | ReActiv8 Implantable Neurostimulation System |
MAINSTAY MEDICAL LIMITED | 06/20/2025 |
P170027
S019 |
30-Day Notice | TherOx Downstream Cartridge | ZOLL Circulation, Inc. | 06/20/2025 |
P170018
S022 |
30-Day Notice | LIFEPAK® CR2 Defibrillator | Physio-Control, Inc | 06/20/2025 |
P160046
S020 |
30-Day Notice | VENTANA PD-L1 (SP263) ASSAY | Ventana Medical Systems, Inc. |
06/20/2025 |
P160029
S028 |
30-Day Notice | HeartStart OnSite Defibrillator (Model M5066A) And HeartStart Home Defibrillator (Model M5068A) |
PHILIPS MEDICAL SYSTEMS, INC. |
06/20/2025 |
P160026
S060 |
30-Day Notice | LIFEPAK 15 Monitor/defibrillator; LIFEPAK 35 Monitor/defibrillator; LIFEPAK 20e Defibrillator/monitor; LIFEPAK 1000 Defi |
Physio-Control. Inc. | 06/20/2025 |
P160026
S059 |
30-Day Notice | LIFEPAK 35 Monitor/defibrillator | Physio-Control. Inc. | 06/20/2025 |
P160022
S040 |
Real-Time Process | X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™ |
ZOLL MEDICAL CORPORATION | 06/20/2025 |
P160015
S018 |
Real-Time Process | AED Plus And Fully Automatic AED Plus |
ZOLL MEDICAL CORPORATION | 06/20/2025 |
P140025
S025 |
30-Day Notice | VENTANA ALK (D5F3) CDX ASSAY | VENTANA MEDICAL SYSTEMS, INC. |
06/20/2025 |
P140003
S127 |
Special (Immediate Track) |
IMPELLA CP With Smart Assist | ABIOMED, INC. | 06/20/2025 |
P130026
S094 |
Real-Time Process | TactiCath Contact Force Ablation Catheter, Sensor Enabled |
St. Jude Medical | 06/20/2025 |
P020055
S032 |
30-Day Notice | PATHWAY® Anti-c-KIT (9.7) Primary Antibody |
VENTANA MEDICAL SYSTEMS, INC. |
06/20/2025 |
P010001
S031 |
30-Day Notice | Transcend® Hip Articulation System | CERAMTEC GMBH | 06/20/2025 |
P980035
S815 |
30-Day Notice | MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE |
MEDTRONIC Inc. | 06/18/2025 |
P980016
S927 |
30-Day Notice | Cobalt MRI ICD DDPB3D1, DDPB3D4; Cobalt MRI ICD DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1, DVPA2D4; Cobalt XT |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
06/18/2025 |
P970004
S425 |
30-Day Notice | InterStim® Therapy System, Verify® Evaluation System |
MEDTRONIC NEUROMODULATION |
06/18/2025 |
P960030
S082 |
30-Day Notice | IsoFlex Optim Lead 1944, 1948 | Abbott Medical | 06/18/2025 |
P960013
S130 |
30-Day Notice | OptiSense 1999; Tendril SDX Lead 1688T/TC DTB; Tendril ST Lead 1888TC, 1882TC; Tendril STS Lead 2088TC; Tendril STS Lead |
Abbott Medical | 06/18/2025 |
P960009
S507 |
30-Day Notice | Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
MEDTRONIC Inc. | 06/18/2025 |
P950037
S273 |
30-Day Notice | Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR- |
BIOTRONIK, INC. | 06/18/2025 |
P950022
S149 |
30-Day Notice | Durata 7120, 7121, 7122, 7130, 7131, 7170, 7171, 7120, 7120Q, 7121Q, 7122, 7122Q, 7170Q, 7171Q, 7172Q; Optisure LDA210, |
Abbott Medical | 06/18/2025 |
P930014
S152 |
Normal 180 Day Track No User Fee |
AcrySof Posterior Chamber Intraocular Lenses And Delivery Systems |
ALCON LABORATORIES, INC. | 06/18/2025 |
P910056
S060 |
30-Day Notice | Envista® Hydrophobic Acrylic Intraocular Lens (IOL) |
Bausch & Lomb, Inc. | 06/18/2025 |
P910023
S480 |
30-Day Notice | Gallant DR CDDRA500Q; Gallant VR CDVRA500Q; Neutrino NxT DR CDDRA800Q; Neutrino NxT DR CDDRA600Q; Neutrino NxT VR CDVRA8 |
Abbott Medical | 06/18/2025 |
P890003
S479 |
30-Day Notice | SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 |
Medtronic, Inc. | 06/18/2025 |
P880086
S344 |
30-Day Notice | P880086 Endurity PM1162, PM2162; Endurity Core PM1140, PM2140; AV Plus Dx Lead 1368; Verity ADx XL 5357M/S, 5356, 5256, |
Abbott Medical | 06/18/2025 |
P860004
S444 |
30-Day Notice | SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
MEDTRONIC Inc. | 06/18/2025 |
P840001
S595 |
30-Day Notice | Restore, Itrel®, Synergy Intellis™, Vanta™ And Inceptiv™ Spinal Cord Stimulation Systems And Pisces™, Specify®, And Vect |
MEDTRONIC NEUROMODULATION |
06/18/2025 |
P240028
S001 |
Normal 180 Day Track No User Fee |
WiSE® (Wireless Stimulation Of The Endocardium Technology) CRT System |
EBR Systems, Inc. | 06/18/2025 |
P240010
S005 |
30-Day Notice | MI Cancer Seek | Caris Life Sciences | 06/18/2025 |
P240001 | Original | PearlMatrix™ Bone Graft | Cerapedics, Inc. | 06/18/2025 |
P230013
S015 |
30-Day Notice | Edwards EVOQUE Tricuspid Valve Replacement System |
Edwards Lifesciences LLC | 06/18/2025 |
P220012
S051 |
30-Day Notice | Aurora EV-ICD System | Medtronic, Inc. | 06/18/2025 |
P190018
S039 |
Normal 180 Day Track No User Fee |
Clareon Aspheric Hydrophobic Acrylic Intraocular Lenses |
Alcon Laboratories, LLC | 06/18/2025 |
P150035
S027 |
30-Day Notice | Aveir LSP112V, LSP201A, LSP202V | Abbott Medical | 06/18/2025 |
P150033
S209 |
30-Day Notice | Micra AV TPS MC1AVR1, Micra AV2 TPS MC2AVR1, Micra TPS MC1VR01, Micra VR2 TPS MC2VR01 |
MEDTRONIC Inc. | 06/18/2025 |
P150016
S026 |
30-Day Notice | TRIDYNE™ Vascular Sealant | NEOMEND, INC. | 06/18/2025 |
P140033
S099 |
30-Day Notice | Endurity MRI PM1172, PM2172; Assurity MRI PM1272, PM2272; Zenex MRI PM1282, PM2282; Zenus MRI PM1182, PM2182; Accent MRI |
Abbott Medical | 06/18/2025 |
P130008
S126 |
30-Day Notice | Inspire® Upper Airway Stimulation (UAS) |
INSPIRE MEDICAL SYSTEMS | 06/18/2025 |
P100044
S057 |
30-Day Notice | PROPEL, PROPEL MINI And PROPEL CONTOUR |
INTERSECT ENT | 06/18/2025 |
P080025
S320 |
30-Day Notice | InterStim® Therapy System, Verify® Evaluation System |
MEDTRONIC NEUROMODULATION |
06/18/2025 |
P080020
S054 |
30-Day Notice | Gel-One | SEIKAGAKU CORP. | 06/18/2025 |
P080012
S075 |
Normal 180 Day Track No User Fee |
PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM |
Infusyn Therapeutics, LLC |
06/18/2025 |
P070008
S168 |
30-Day Notice | Edora 8 HF-T QP 407137, Edora 8 HF-T 407138, Evity 8 HF-T QP 407139, Evity 8 HF-T 407140, Enitra 8 HF-T QP 407141, Enitr |
BIOTRONIK, INC. | 06/18/2025 |
P050023
S198 |
30-Day Notice | Acticor 7 VR-T 429526, Rivacor 7 VR-T 429536, Rivacor 5 VR-T 429565, Rivacor 3 VR-T 429574, Acticor 7 VR-T DX 429525, Ri |
BIOTRONIK, INC. | 06/18/2025 |
P040020
S111 |
Normal 180 Day Track No User Fee |
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses |
Alcon Research, Ltd. | 06/18/2025 |
P030054
S437 |
30-Day Notice | Avant HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Entrant HF CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T; Gallant HF C |
Abbott Medical | 06/18/2025 |
P030053
S081 |
30-Day Notice | MENTOR™ MemoryGel™ Enhance Breast Implants |
MENTOR CORP. | 06/18/2025 |
P030035
S210 |
30-Day Notice | Allure™ PM3120; Allure Quadra™ RF PM3242; Allure Quadra™ PM3140; Allure RF PM3222; Anthem PM3210; Quadra Allure PM3542; |
Abbott Medical | 06/18/2025 |
P010047
S071 |
30-Day Notice | PROGEL™ Pleural Air Leak Sealant | NEOMEND, INC. | 06/18/2025 |
P010031
S893 |
30-Day Notice | Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4; Brava CRT-D DTBC1D1; Bra |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
06/18/2025 |
P010015
S565 |
30-Day Notice | Consulta CRT-P C4TR01; Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRTP W4TR01; Serena Bipolar CRT-P W1TR02; Ser |
MEDTRONIC Inc. | 06/18/2025 |
P980035
S813 |
30-Day Notice | Astra S DR MRI IPG, X3DR01; Astra S SR MRI IPG, X3SR01; Astra XT DR MRI IPG, X1DR01; Astra XT SR MRI IPG, X1SR01; Azure |
MEDTRONIC Inc. | 06/17/2025 |
P890003
S477 |
30-Day Notice | CareLink SmartSync Device Manager Base, 24970A |
Medtronic, Inc. | 06/17/2025 |
P240031 | Original | Neuspera Sacral Neuromodulation System |
Neuspera Medical Inc | 06/17/2025 |
P200002
S011 |
Normal 180 Day Track No User Fee |
EPi-Sense Guided Coagulation System | AtriCure, Inc. | 06/17/2025 |
P180035
S029 |
30-Day Notice | MiSight 1 Day (omafilcon A) | CooperVision, Inc. | 06/17/2025 |
P180035
S028 |
30-Day Notice | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses For Daily Wear |
CooperVision, Inc. | 06/17/2025 |
P100046
S019 |
Normal 180 Day Track No User Fee |
Synergy Ablation System | ATRICURE INC. | 06/17/2025 |
P010015
S564 |
30-Day Notice | Percepta Bipolar CRT- P, WlTR0l; Percepta Quadripolar CRT-P, W4TR01; Serena Bipolar CRT-P, W1TR02; Serena Quadripolar CR |
MEDTRONIC Inc. | 06/17/2025 |
P190031
S013 |
30-Day Notice | VENTANA HER2 DualL ISH DNA Probe Cocktail |
Ventana Medical Systems, Inc. |
06/16/2025 |
P090026
S032 |
Normal 180 Day Track | Access Hybritech P2psa | BECKMAN COULTER, INC. | 06/16/2025 |
P050052
S169 |
30-Day Notice | RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline |
MERZ NORTH AMERICA, INC | 06/16/2025 |
P050037
S145 |
30-Day Notice | RADIESSE® Injectable Implant | MERZ NORTH AMERICA, INC | 06/16/2025 |
P040047
S077 |
30-Day Notice | COAPTITE® | MERZ NORTH AMERICA, INC | 06/16/2025 |
P980035
S812 |
30-Day Notice | Adapta, Versa, Sensia IPG ADDRS1, VEDR01; Adapta, Versa, Sensia IPG ADDR03, ADDRL1, ADSR03, SESR01; Adapta, Versa, Sensi |
MEDTRONIC Inc. | 06/13/2025 |
P980016
S925 |
30-Day Notice | Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
06/13/2025 |
P230017
S006 |
30-Day Notice | PulseSelect™ Pulsed Field Ablation (PFA) System |
Medtronic, Inc. | 06/13/2025 |
P220012
S049 |
30-Day Notice | Aurora EV ICD DVEA3E4 | Medtronic, Inc. | 06/13/2025 |
P150033
S207 |
30-Day Notice | Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 |
MEDTRONIC Inc. | 06/13/2025 |
P130006
S109 |
30-Day Notice | GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis With Heparin Bioactive Surface |
W.L. GORE & ASSOCIATES,INC |
06/13/2025 |
P040037
S170 |
30-Day Notice | GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis With Heparin Bioactive Surface |
W.L. GORE & ASSOCIATES,INC |
06/13/2025 |
P010031
S891 |
30-Day Notice | Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4, Brava CRT-D DTBC1D1; Bra |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
06/13/2025 |
P010015
S563 |
30-Day Notice | Consulta CRT-P C4TR01, Percepta Bipolar CRT-P W1TR01, Percepta Quadripolar CRT-P W4TR01, Serena Bipolar CRTP W1TR02, Ser |
MEDTRONIC Inc. | 06/13/2025 |
P230040
S016 |
30-Day Notice | Cordella Pulmonary Artery Sensor System (CorPASS) |
Endotronix, Inc. | 06/12/2025 |
P200046
S042 |
30-Day Notice | Harmony Transcatheter Pulmonary Valve System |
Medtronic, Inc. | 06/12/2025 |
P100040
S073 |
30-Day Notice | Valiant Thoracic Stent Graft With The Captivia Delivery System |
Medtronic Vascular | 06/12/2025 |
P100021
S130 |
30-Day Notice | Endurant Stent Graft System | Medtronic Vascular | 06/12/2025 |
P070008
S165 |
Normal 180 Day Track No User Fee |
Sentus QP Pacing Leads | BIOTRONIK, INC. | 06/12/2025 |
P060011
S041 |
30-Day Notice | C-flex Lntraocular Lens; C-flex Aspheric Lntraocular Lens; 6.0 Mm Aspheric Lntraocular Lens; RayOne Aspheric; RayOne Sph |
RAYNER INTRAOCULAR LENSES LTD. |
06/12/2025 |
P050023
S193 |
Normal 180 Day Track No User Fee |
Sentus QP Pacing Leads | BIOTRONIK, INC. | 06/12/2025 |
P990081
S056 |
Normal 180 Day Track | PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody |
VENTANA MEDICAL SYSTEMS, INC. |
06/11/2025 |
P210032
S020 |
30-Day Notice | GORE TAG Thoracic Branch Endoprosthesis (TBE Device) |
W. L. Gore & Associates, Inc. |
06/11/2025 |
P160055
S046 |
Real-Time Process | Light Adjustable Lens, Light Delivery System |
RxSight, Inc. | 06/11/2025 |
P020004
S199 |
30-Day Notice | GORE® EXCLUDER® AAA Endoprosthesis | W.L. GORE & ASSOCIATES,INC |
06/11/2025 |
N16837
S036 |
30-Day Notice | Artegraft Collagen Vascular Graft | LeMaitre Vascular, Inc. | 06/11/2025 |
P960009
S503 |
Real-Time Process | Activa™ And Percept™ Deep Brain Stimulation Therapy System |
MEDTRONIC Inc. | 06/10/2025 |
P930021
S033 |
Normal 180 Day Track | BIORA EMDOGAIN(R) | THE STRAUMANN COMPANY | 06/10/2025 |
P200039
S015 |
Normal 180 Day Track | Shockwave Intravascular Lithotripsy (IVL) System With Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Cathete |
Shockwave Medical, Inc. | 06/10/2025 |
P200035
S022 |
Real-Time Process | OrganOx Metra System | OrganOx Limited | 06/10/2025 |
P050052
S168 |
30-Day Notice | RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, Jawline Indication |
MERZ NORTH AMERICA, INC | 06/10/2025 |
P050037
S144 |
30-Day Notice | RADIESSE® Injectable Implant | MERZ NORTH AMERICA, INC | 06/10/2025 |
N17600
S043 |
Normal 180 Day Track | Avitene Flowable Collagen Hemostat | DAVOL, INC., SUB. C.R. BARD, INC. |
06/10/2025 |
BP220799
S014 |
Normal 180 Day Track | RECELL Autologous Cell Harvesting Device |
Avita Medical | 06/10/2025 |
BP170154
S028 |
30-Day Notice | ID CORE XT | Progenika Biopharma, S.A. |
06/10/2025 |
BP170154
S027 |
30-Day Notice | ID CORE XT | Progenika Biopharma, S.A. |
06/10/2025 |
BP170122
S952 |
Normal 180 Day Track | ReCell Autologous Cell Harvesting Device |
Avita Medical | 06/10/2025 |
P980040
S172 |
30-Day Notice | SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS |
Johnson & Johnson Surgical Vision, Inc. |
06/09/2025 |
P840001
S591 |
Real-Time Process | Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int |
MEDTRONIC NEUROMODULATION |
06/09/2025 |
P240010
S004 |
30-Day Notice | MI Cancer Seek | Caris Life Sciences | 06/09/2025 |
P180028
S016 |
30-Day Notice | HeartStart FRx Defibrillator (861304) |
Philips Medical Systems | 06/09/2025 |
P160029
S027 |
30-Day Notice | HeartStart Home Defibrillator (M5068A) And HeartStart Onsite Defibrillator (M5066A) |
PHILIPS MEDICAL SYSTEMS, INC. |
06/09/2025 |
P140009
S116 |
Normal 180 Day Track | Liberta RC Deep Brain Stimulation Implantable Pulse Generator |
Abbott Medical | 06/09/2025 |
P010032
S234 |
Normal 180 Day Track | Eterna Spinal Cord Stimulation Implantable Pulse Generator |
Abbott Medical | 06/09/2025 |
P230013
S014 |
30-Day Notice | EVOQUE Tricuspid Valve Replacement System |
Edwards Lifesciences LLC | 06/06/2025 |
P210025
S006 |
Normal 180 Day Track No User Fee |
SurVeil Drug-Coated Balloon | Surmodics, Inc. | 06/06/2025 |
P100034
S040 |
30-Day Notice | Optune® | Novocure GmbH | 06/06/2025 |
P980016
S923 |
30-Day Notice | Cobalt MRI ICD DDPB3D1; Cobalt MRI ICD DVPB3D1; Cobalt XT MRI ICD DDPA2D1; Cobalt XT MRI ICD DVPA2D1; Crome MRI ICD DDPC |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
06/05/2025 |
P980016
S913 |
135 Review Track For 30-Day Notice |
Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
06/05/2025 |
P930039
S268 |
135 Review Track For 30-Day Notice |
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
Medtronic, Inc. | 06/05/2025 |
P240006
S008 |
30-Day Notice | VARIPULSE Bi-Directional Catheter | Biosense Webster, Inc | 06/05/2025 |
P230023
S008 |
30-Day Notice | GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis |
W.L. Gore & Associates, Inc. |
06/05/2025 |
P230020
S004 |
30-Day Notice | Altius® Direct Electrical Nerve Stimulation System |
Neuros Medical, Inc. | 06/05/2025 |
P210032
S021 |
30-Day Notice | GORE TAG Thoracic Branch Endoprosthesis |
W. L. Gore & Associates, Inc. |
06/05/2025 |
P200030
S021 |
30-Day Notice | GORE EXCLUDER Conformable AAA Endoprosthesis (EXCC) |
W. L. Gore and Associates, Inc. |
06/05/2025 |
P200030
S020 |
30-Day Notice | GORE EXCLUDER Conformable AAA Endoprosthesis |
W. L. Gore and Associates, Inc. |
06/05/2025 |
P200022
S016 |
135 Review Track For 30-Day Notice |
Simplify® Cervical Artificial Disc | NuVasive, Inc. | 06/05/2025 |
P130006
S108 |
30-Day Notice | GORE® VIABAHN® Endoprosthesis With Heparin Bioactive Surface |
W.L. GORE & ASSOCIATES,INC |
06/05/2025 |
P100047
S229 |
30-Day Notice | HeartWare™ Ventricular Assist System (HVAD) |
Medtronic | 06/05/2025 |
P090013
S335 |
135 Review Track For 30-Day Notice |
CapSureFix MRI Lead | Medtronic, Inc | 06/05/2025 |
P040043
S142 |
30-Day Notice | Conformable GORE® TAG® Thoracic Endoprosthesis |
W. L. GORE & ASSOCIATES, INC. |
06/05/2025 |
P040037
S169 |
30-Day Notice | GORE® VIABAHN® Endoprosthesis | W.L. GORE & ASSOCIATES,INC |
06/05/2025 |
P020004
S200 |
30-Day Notice | GORE® EXCLUDER® AAA Endoprosthesis | W.L. GORE & ASSOCIATES,INC |
06/05/2025 |
P010031
S889 |
30-Day Notice | Amplia MRI CRTD DTMB1D1; Amplia MRI Quad CRT-D DTMB1Q1; Brava CRT-D DTBC1D1; Brava Quad CRTD DTBC1Q1; Claria MRI CRT-D D |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
06/05/2025 |
P010031
S879 |
135 Review Track For 30-Day Notice |
Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
06/05/2025 |
P010001
S030 |
30-Day Notice | Ceramic TRANSCEND® Hip Articulation System |
CERAMTEC GMBH | 06/05/2025 |
P910073
S181 |
30-Day Notice | Endotak Lead System | BOSTON SCIENTIFIC | 06/04/2025 |
P240036
S001 |
30-Day Notice | OmniaSecure™ MRI SureScan™ Lead Model 3930M |
Medtronic, Inc. | 06/04/2025 |
P240027
S002 |
Real-Time Process | SpineSeal Spine Sealant | Pramand, LLC | 06/04/2025 |
P240010
S003 |
Real-Time Process | MI Cancer Seek | Caris Life Sciences | 06/04/2025 |
P230042
S002 |
30-Day Notice | Optune Lua | Novocure GmbH | 06/04/2025 |
P230013
S012 |
Normal 180 Day Track No User Fee |
EVOQUE Tricuspid Delivery System: 9850TDS EVOQUE Dilator Kit: 9850DK EVOQUE Loading System: 9850LS |
Edwards Lifesciences LLC | 06/04/2025 |
P220014
S007 |
30-Day Notice | CraniSeal Dural Sealant | Pramand, LLC | 06/04/2025 |
P220003
S022 |
Normal 180 Day Track No User Fee |
PASCAL Precision Implant System: 20000IS And 20000ISM PASCAL Precision Guide Sheath: 20000GS |
Edwards LifeSciences LLC | 06/04/2025 |
P200015
S063 |
Normal 180 Day Track No User Fee |
Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29 |
Edwards Lifesciences, LLC |
06/04/2025 |
P180047
S035 |
Real-Time Process | LIAISON QuantiFERON -TB Gold Plus And LIAISON Control QuantiFERON -TB Gold Plus |
DiaSorin, Inc. | 06/04/2025 |
P180038
S024 |
Real-Time Process | LIAISON MUREX Anti-HBc And LIAISON MUREX Control Anti-HBc |
DiaSorin Inc. | 06/04/2025 |
P160054
S101 |
Real-Time Process | HeartMate 3™ Left Ventricular Assist System |
Abbott Medical | 06/04/2025 |
P140031
S186 |
Normal 180 Day Track No User Fee |
Edwards Certitude Delivery System: 9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9630TA20, 9630TA23, 9630TA26, 9630TA29 Ed |
EDWARDS LIFESCIENCES, LLC. |
06/04/2025 |
P110041
S014 |
Normal 180 Day Track | ADVIA Centaur HBsAgII (HBsII) | SIEMENS CORP. | 06/04/2025 |
P100047
S228 |
30-Day Notice | HEARTWARE VENTRICULAR ASSIST SYSTEM | Medtronic | 06/04/2025 |
P100018
S051 |
30-Day Notice | Pipeline™ Flex Embolization Device (Pipeline™ Flex); Pipeline™ Flex Embolization Device With Shield Technology™ (Pipelin |
Micro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR |
06/04/2025 |
P070001
S028 |
Normal 180 Day Track No User Fee |
Prodisc C, Prodisc C Vivo, Prodisc C Nova, Prodisc C SK |
Centinel Spine, LLC | 06/04/2025 |
P060040
S116 |
Real-Time Process | HeartMate II™ Left Ventricular Assist System |
Abbott Medical | 06/04/2025 |
P050010
S025 |
Normal 180 Day Track No User Fee |
PRODISC -L TOTAL DISC REPLACEMENT DEVICE |
Centinel Spine, LLC | 06/04/2025 |
P010012
S590 |
30-Day Notice | NAV 2 Quadpole LV Long Spiral; NAV 2 Quadpole LV Straight; NAV 2 Quadpole LV Short Spiral |
Boston Scientific Corp. | 06/04/2025 |
P150038
S039 |
Real-Time Process | Exablate Model 4000 System Type 1.0 And 1.1 System (“Exablate Neuro”; “Exablate Prime”) |
InSightec | 06/03/2025 |
P130008
S116 |
135 Review Track For 30-Day Notice |
Inspire Upper Airway Stimulation (UAS) |
INSPIRE MEDICAL SYSTEMS | 06/03/2025 |
P130005
S047 |
30-Day Notice | Diamondback 360 Coronary Orbital Atherectomy System; Diamondback 360 Precision Coronary Orbital Atherectomy System |
CARDIOVASCULAR SYSTEMS, INC. |
06/03/2025 |
P000053
S137 |
Real-Time Process | AMS 800 Artificial Urinary Sphincter (AUS) With And Without Lnhibizone |
Boston Scientific Corp. | 06/03/2025 |
P220020
S006 |
30-Day Notice | Lava Liquid Embolic System (Lava LES) |
BlackSwan Vascular, Inc. | 06/02/2025 |
P200035
S019 |
Normal 180 Day Track | OrganOx Metra® System | OrganOx Limited | 06/02/2025 |
P170038
S024 |
30-Day Notice | CentriMag Circulatory Support System | Abbott | 06/02/2025 |
P980035
S811 |
30-Day Notice | Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01 Astra S DR MRI IPG X3DR01 Astra S SR MRI IPG X3SR |
MEDTRONIC Inc. | 05/30/2025 |
P920015
S299 |
30-Day Notice | HV Splitter/Adaptor Kit (5019); Sprint Quattro Lead (6947M); Sprint Quattro Lead (6946M); Sprint Quattro Lead (6935M) |
MEDTRONIC Inc. | 05/30/2025 |
P910056
S059 |
30-Day Notice | Envista Hydrophobic Acrylic Intraocular Lens (IOL), Envista Toric Hydrophobic Acrylic Intraocular Lens (IOL), Envista As |
Bausch & Lomb, Inc. | 05/30/2025 |
P240013
S007 |
Normal 180 Day Track No User Fee |
Sphere-9 Catheter And Affera Ablation System |
Medtronic Inc. | 05/30/2025 |
P240005
S004 |
30-Day Notice | Envista Envy™ Hydrophobic Acrylic Intraocular Lens (IOL), Envista Envy™ Toric Hydrophobic Acrylic Intraocular Lens (IOL) |
Bausch & Lomb, Inc. | 05/30/2025 |
P220012
S050 |
30-Day Notice | Epsila EV Extravascular Lead (EV2401) |
Medtronic, Inc. | 05/30/2025 |
P210007
S006 |
30-Day Notice | Vivistim® System | MicroTransponder, Inc. | 05/30/2025 |
P200041
S008 |
30-Day Notice | Scoreflex NC Scoring PTCA Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. |
05/30/2025 |
P200039
S016 |
30-Day Notice | Shockwave Intravascular Lithotripsy (IVL) System With Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter |
Shockwave Medical, Inc. | 05/30/2025 |
P170034
S015 |
30-Day Notice | Hydrus® Microstent | Ivantis, Inc. wholly-owned subsidiary of Alcon Research, LLC |
05/30/2025 |
P170024
S023 |
30-Day Notice | Surpass Streamline Flow Diverter | Stryker Neurovascular | 05/30/2025 |
P170008
S057 |
30-Day Notice | EluNIR™ Ridaforolimus Eluting Coronary Stent System |
Medinol, Ltd. | 05/30/2025 |
P160022
S044 |
30-Day Notice | AED 3 BLS | ZOLL MEDICAL CORPORATION | 05/30/2025 |
P160015
S022 |
30-Day Notice | AED 3 Semi-Automatic, AED 3 Fully Automatic |
ZOLL MEDICAL CORPORATION | 05/30/2025 |
P130008
S125 |
30-Day Notice | INSPIRE II UPPER AIRWAY STIMULATOR | INSPIRE MEDICAL SYSTEMS | 05/30/2025 |
P020018
S064 |
Panel Track | Zenith® Iliac Branch | COOK, INC. | 05/30/2025 |
P010030
S193 |
30-Day Notice | WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST |
ZOLL MANUFACTURING CORPORATION |
05/30/2025 |
P010030
S191 |
Real-Time Process | WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST |
ZOLL MANUFACTURING CORPORATION |
05/30/2025 |
P010015
S562 |
30-Day Notice | Consulta CRT-P C4TR01, Percepta Bipolar CRT-P W1TR01, Percepta Quadripolar CRT-P W4TR01, Serena Bipolar CRTP W1TR02, Ser |
MEDTRONIC Inc. | 05/30/2025 |
BP170122
1115 |
30-Day Notice | ReCell Autologous Cell Harvesting Device |
Avita Medical | 05/30/2025 |
P980040
S173 |
30-Day Notice | Intraocular Lenses (IOLs) In The DaisyWheel And TECNIS SIMPLICITY Delivery System |
Johnson & Johnson Surgical Vision, Inc. |
05/29/2025 |
P220014
S006 |
30-Day Notice | CraniSeal Dural Sealant | Pramand, LLC | 05/29/2025 |
P220002
S008 |
30-Day Notice | TOPS™ System | Premia Spine Ltd. | 05/29/2025 |
P200041
S007 |
30-Day Notice | Scoreflex NC Scoring PTCA Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. |
05/29/2025 |
P200022
S017 |
30-Day Notice | Simplify® Cervical Artificial Disc | NuVasive, Inc. | 05/29/2025 |
P190008
S039 |
30-Day Notice | IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
Medtronic Vascular Inc. | 05/29/2025 |
P150031
S085 |
Special (Immediate Track) |
VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM |
Boston Scientific Corp. | 05/29/2025 |
P140010
S092 |
30-Day Notice | IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C |
MEDTRONIC Inc. | 05/29/2025 |
P040045
S140 |
30-Day Notice | VISTAKON® (senofilcon A) Brand Contact Lenses |
VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR |
05/28/2025 |
P020036
S055 |
Special (Immediate Track) |
S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM |
Cordis US Corporation | 05/28/2025 |
P010031
S890 |
30-Day Notice | Cobalt MRI CRT-D DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ; Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ; Crome MRI C |
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
05/28/2025 |
P010029
S041 |
30-Day Notice | EUFLEXXA (1% SODIUM HYALURONATE) | FERRING PHARMACEUTICALS, INC. |
05/28/2025 |
P000053
S139 |
30-Day Notice | AMS 800™ Artificial Urinary Sphincter (AUS) |
Boston Scientific Corp. | 05/28/2025 |
P000006
S070 |
Normal 180 Day Track No User Fee |
Titan Inflatable Penile Prosthesis | COLOPLAST CORP. | 05/28/2025 |
N970012
S207 |
30-Day Notice | AMS 700™ Inflatable Penile Prosthesis Without InhibiZone™ |
Boston Scientific Corp. | 05/28/2025 |