
The FDA’s Center for Devices & Radiological Health released a selection of summary review memos detailing applications to make substantial changes to already-approved medical devices.
The federal watchdog agency’s med-tech oversight arm said it began releasing the documents as part of the CDRH’s transparency initiative.
The 180-day supplements seek to make "a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report," according to the agency.
The table below details the latest release, posted to the FDA’s website, which includes PMA memos and approval orders related to design changes over the latest 3-month period.
Device Name |
PMA Number |
Review Memo |
Approval Order |
Reocor S / D Family Of External Pacemakers |
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Frontier/Frontier Ii/Anthem Family Of Crt-Ps |
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Epic Hf/Atlas+Hf/Quadra Assura/Unify Assura Family Of Crt-Ds |
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Sensolog/Dialog/Regency Family Of Pacemakers |
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Affinity/Integrity/Victory/Zephyr/Accent Family Of Pacemakers |
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Cadence/Ellipse/Fortify Assura Family Of Icds |
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Microny Family Of Pacemakers |
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Belos Dr/Dr-T/Vr/Vr-T/Lexos Dr/Dr-T/Vr/Vr-T/Lumos Dr-T/Vr-T/Xelos Dr-T |
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Lumax 300/340/500/540 Dr/Dr-T/Vr/Vr-T/Lumax 540 Vr-T Dx/Kronos Lv-T/Lumax 300/340/500/540 Hf/Hf-T |
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Stratos Lv/Lv-T |
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Cylos/Dr/Dr-T/Vr/Dromos Dr/Sr/Sl/Kairos Dr/Sr/Sl/D/S/Philos/Dr/Dr-T/Sr/Slr/D/S/Philos Ii D/Dr/S/Slr/Sr/Dr-T/Protos Dr/Cl |
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Medtronic Carelink Monitor, Cardiosight Reader |
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Protects Xt Vr, Protecta Vr, Secura Vr Maximo Ii Icd |
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Invive V172, V173 |
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Spectranetics Laser Sheath Device |
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Epic Hf/Atlas + Hf Family |
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Cadence Family Of Icds |
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Vigila And Volta And Passive Fixation Bipolar Steroid Eluting Icd Leads |
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Cellpaker Plasma Collection Device |
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Medtronic Consulta Crt-D D204trm, Maximo Ii Crt-D D264trm Implantable Cardioverter Defibrillators |
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Carelink Home Monitor Model 2490c, Cardiosight Reader Model 2020a, Caelink Network Device |
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Medtronic Sprint Quattro Secure Lead Model 6947m |
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Medtronic Secura Dr D204drm, Maximo Ii D264drm, Implantable Cardioverter Defibrillators |
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Endotak Reliance Is-I Passive Fixation |
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Cardiac Resynchronization Therapy Defibrillator (Crt-D) |
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Model 4195 Attain Starfix Lead |
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Incepta, Energen, Punctua And Cognis Crt-D |
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Lumax 500/540 Icds Thoracic Impedance |
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Incepta, Energen, Punctua And Teligen Icds |
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Medtronic Protecta Xt Crt-D D314trm And Protecta Crt-D D334 Implantable Cardioverter Defibrillators |
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Medtronic Carelink Monitor Model 2490c, Cardiosight Reader |
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Medtronic Protecta Xt Dr D314drm, Protecta Dr D334drm, Cardioverter Defibrillators |
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Tendril Sts 1988tc And 2088tc |
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Radiesse Injectable Implant |
P050037/S024 |
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Radiesse Injectable Implant |
P050052/S027 |
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Lexos Dr/Dr-T/Vr/Vr-T/Lumos Dr-T/Vr-T Icds |
P000009/S046 |
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Lumax 300/340 Vr-T/Dr-T/Hf-T/Lumax 500/540 Vr-T/Dr-T/Hf-T/Lumax 540 Vr-T Dx |
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Corox Otw-L Bp Leads |
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Evia/Entovis/Estella/Effecta/Ecuro |
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Transcyte Human Fibroblast-Derived Temporary Skin Substitute |
P960007/S021 |
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Concerto Ii/Consulta/Insync Ii Marquis/Iii Marquis/Insync Maximo/Sentry/Maximo Ii/Protecta/Protecta Xt |
P010031/S252 |
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Entrust/Intrinsic/Marquis/Maximo/Ii/Protecta Xt/Icd/Secura/Virtuoso Ii |
P980016/S298 |
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Frontier/Frontierii/Anthem Family Of Crt-Ps |
P030035/S083 |
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Epic Hf/Atlas + Hf Family Of Crt-Ds |
P030054/S189 |
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Sensolog/Dialog/Regency Family Of Pacemakers |
P880006/S071 |
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Affinity/Integrity/Victory/Zephyr/Accent Family Of Pacemakers |
P880086/S203 |
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Cadence Family Of Icds |
P910023/S264 |
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Microny Family Of Pacemakers |
P970013/S040 |
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Restylane Injectable Gel |
P040024/S052 |
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Epic Hf/Atlas+Hf/Promote/Unify Families Of Crt-Ds |
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Cadence/Current/Fortify Families Of Icds |
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Surgifoam Hemostatic Matrix And Surgiflo Hemostatic Matrix Kit With Thrombin |
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Transvene Cs/Svc Lead |
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Dema Ipg/C & T Series Ipgs |
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Insync Crt-P/Insync Iii Crt-P |
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Concerto Ii/Maximo Ii/Consulta Crt-Ds |
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Dual Chamber, Implantable Pulse Generator |
P820003/S104 |
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Medtronic Carelink Programmer |
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Medtronics Carelink Home Monitor And Cardiosight Reader |
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Ace Header/Lead End Pin Cap/Epicardial Patch Lead/Accessory (Upsizing Sleeve) For Unipolar |
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Legend Plus Family Of Pacemakers |
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Kappa 400 Dr/Sr Ipgs |
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Virtuoso Ii/Secura/Maximo Ii Icds |
P980016/S273 |
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Kappa 600/700/650/800/900/Relia/Sigma/Medtronic 350/Enpulse/Enrhythm/At500/Adapta/Versa/Sensia Ipgs |
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Carelink Home Monitor And Cardiosight Monitor |
P890003/S209 |
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Reliaty / Model 3145 Family Of Pacing System Analyzers |
P950037/S088 |
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Lifevest Wearable Defibrillator |
P010030/S023 |
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Implantable Cv Defibrillator/Pacemaker Programmer/Icd Monitoring System |
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Lumax 300/340/500/540 Dr/Dr-T/Vr/Vr-T/Lumax 540 Vr-T Dx/Kronos Lv-T/Lumax 300/340/500/540 Hf/Hf-T |
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Stratos Lv/Lv-T |
P070008/S019 |
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Implantable Pacemaker Pulse Generator,Pacemaker Programming |
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Consulta Crt-D/Concerto Ii Crt-D/Maximo Crt-D Icds |
P010031/S150 |
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Frontier/Frontier Ii Family Of Crt-Ps |
P030035/S075 |
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Epic Hf/Atlas+Hf Hamily Of Crt-Ds |
P030054/S177 |
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Sensolog/Dialog/Regency Family Of Pacemakers |
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Affinity/Integrity/Victory Family Of Pacemakers |
P880086/S195 |
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Carelink Monitor & Cardiosight Reader |
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Cadence Family Of Icds |
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Microny Family Of Pacemakers |
P970013/S038 |
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Secura Dr/Vr, Virtuoso Ii Dr/Vr, Maximo Ii Dr/Vr Icds |
P980016/S187 |
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Advisa Dr Ipg |
P980035/S134 |
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Medtronic Attain Ability Plus Model 4296 Lead |
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Medtronic Attain Ability Straight Model 4396 Left Ventricular Lead |
P080006/S004 |
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Medtronic Selectsecure Lead Model 3830 |
P030036/S004 |
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Medtronic Carelink Monitor Model 2490c, Cardiosight Reader |
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Evia / Entovis Family Of Pulse Generators |
P950037/S091 |
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Medtronic Protecta Xt Dr D314drg, Protecta Xt Vr D314vrg, Protecta Dr D334drg, Implantable Cardioverter Defibrillators |
P980016/S211 |
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Protecta Xt Crt-D And Protecta Crt-D Implantable Cardioverter Defibrillators With Cardiac Resynchronization; Model Sw009 |
P010031/S171 |
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Consulta & Syncra Crt-Ps Implantable Pulse Generator With Cardiac Resynchronization |
P010015/S084 |
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Insync Crt-P & Insync Iii Crt-P |
P010015/S086 |
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Concerto Ii/Consulta/Maximo Ii Crt-Ds |
P010031/S198 |
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Carelink Monitor Models 2490g/2491ddma |
P890003/S189 |
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Carelink Ddma Software And Carelink Monitor |
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Kappa 400 Dr/Sr Ipg |
P970012/S068 |
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Secura Dr/Vr/Maximo Ii Vr/Dr/Virtuoso Ii Dr/Vr Icds |
P980016/S240 |
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Kappa 600/700/650/800/900/Relia/Sigma/Medtronic 350/Enpulse/Enrhythm/At500/Adapta/Versa/Senia Ipgs |
P980035/S168 |
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Dema Ipg/C & T Series Ipgs |
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Frontier/Frontier 2 Family Of Crt-Ps |
P030035/S070 |
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Epic Hr/Atlas + Hf Family Of Crt-Ds |
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Senslog/Dialog/Regency Family Of Pacemakers |
P880006/S067 |
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Affinity/Integrity/Victory Family Of Pacemakers |
P880086/S189 |
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Cadence Family Of Icds |
P910023/S236 |
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Microny Family Of Pacemakers |
P970013/S034 |
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Durata Family Of Leads |
P950022/S069 |
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Corox Otw-L Bp Left Ventricular Pacing Lead |
P070008/S015 |
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Medtronics Adapta, Versa, Sensia And Relia Implantable Pulse Generator |
P980035/S150 |
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Belos/Lexos Dr/Dr-T/Vr/Vr-T, Lumos Dr-T, & Xelos Dr-T Icds |
P000009/S040 |
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Various Models Of Lumax Icd/Crt-D Families |
P050023/S033 |
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Stratos Lv/Lv-T Crt-P |
P070008/S017 |
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Evia/Entovis Dr/Dr-T/Sr-T & Various Other Models Of Pulse Generators |
P950037/S083 |
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Optisense Model 1999 Lead |
P960013/S057 |
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Lead Tunneler Model 6888 |
P830060/S062 |
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Endotak Reliance 4-Site Leads And Accessories |
P910073/S077 |
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Teligen 4-Site Models |
P960040/S198 |
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Cognis 4-Site Models |
P010012/S212 |
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Carelink Ddma Software And Carelink Monitor |
P890003/S191 |
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Enrythm Ipg |
P980016/S237 |
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Entrust Icd Family |
P980035/S166 |
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Linox Smart Steroid-Eluting Dual-Coil Icd Leads |
P980023/S038 |
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Paradym Implant Software Version W2.8.4, And Associated Programmer Software Smartview 2.22ug1 |
P060027/S026 |
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Paradym Implant Software Version W2.8.4, And Associated Programmer Software Smartview 2.22ug1 |
P980049/S059 |
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Reliaty/Model 3145 Pacing System Analyzer |
P950037/S079 |
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Xc202 Ceramic Capacitor |
P980035/S153 |
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Quickflex U Model 1258t Lead |
P030054/S130 |
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Evia/Entovis Pulse Generators |
P000009/S035 |
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Unify Crt-D System |
P030054/S141 |
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Kronos Lv-T And Lumax 300/340 & 500/540 Hf/Hf-T |
P050023/S024 |
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Evia/Entovis Pulse Generators |
P070008/S011 |
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Fortify Dr / Vr Icd Systems |
P910023/S226 |
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Evia / Entovis & Various Other Pulse Generators |
P950037/S072 |
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St Jude Medical, Merlin Psa Ex3100 System |
P030054/S146 |
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Tendril Sts Lead Model 1988tc |
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Paradym Crt-D Model 8750 |
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Paradym Vr Model 8250 & Dr Model 8550 |
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Epic Hf Crt-D System |
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Restylane L And Perlane L Injectable Gels |
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Cadence Family Of Icds |
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Juvederm Ultra Xc And Juvederm Ultra Plus Xc |
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Floseal Hemostatic Matrix 5 Ml/10 Ml Kit |