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Home » FDA releases 180-day PMA memos

FDA releases 180-day PMA memos

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FDA

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 yesterday.

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Device Name PMA Number Review
Memo		 Approval
Order
Attain Ability Straight Model 4396 Left Ventricular Lead P080006/S004 Review1 Approval
2
Attain Ability Plus Model 4296 Lead P080006/S002 Review3 Approval4
Renamic Programmer and software version PSW 1004.U P070008/S019 Review5 Approval6
Evia/Entovis Pulse Generators P070008/S017 Review7 Approval8
Corox OTW-L BP Left Ventricular Lead P070008/S015 Review9 Approval10
Evia/Entovis Pulse Generators P070008/S011 Review11 Approval12
Paradym CRT-D Model 8750 P060027/S026 Review13 Approval14
Paradym CRT-D Model 8750 with Hardware and Manufacturing Changes and Labeling and Programmer Software Changes to the Ovatio VR Model 6250, DR Model 6550 and CRT-D Model 6750 P060027/S015 Review15 Approval16
Juvederm Ultra XC and Juvederm Ultra Plus XC P050047/S005 Review17 Approval18
Renamic Programmer and software version PSW 1004.U P050023/S039 Review19 Approval20
Evia/Entovis Pulse Generators P050023/S033 Review21 Approval22
Evia/Entovis Pulse Generators P050023/S024 Review23 Approval24
Restylane Injectable Gel P040024/S052 Review25 Approval26
Restylane L and Perlane L Injectable Gels P040024/S039 Review27 Approval28
Epic HF/Atlas+HF Family of CRT-Ds P030054/S189 Review29 Approval30
Epic HF/Atlas+HF/Promote/Unify Family of CRT-Ds P030054/S181 Review31 Approval32
Epic HF/Atlas+HF Family of CRT-Ds P030054/S177 Review33 Approval34
Model 3330 Version 11.1 Software for the Model 3650 Merlin Patient Care System P030054/S153 Review35 Approval36
Merlin Patient Care System (PCS) programmer model 3650 P030054/S146 Review37 Approval38
Unify CRT-D Models CD3231-40 and CD3231-40Q P030054/S141 Review39 Approval40
Epic HF CRT-D System P030054/S131 Review41 Approval42
QuickFlex μ Model 1258T Left Ventricular Lead P030054/S130 Review43 Approval44
SelectSecure Model 3830 Lead P030036/S004 Review45 Approval46
Frontier/Frontier II/Anthem Family of CRT-Ps P030035/S083 Review47 Approval48
Frontier/Frontier II Family of CRT-Ps P030035/S075 Review49 Approval50
Model 3330 Version 11.1 Software for the Model 3650 Merlin Patient Care System P030035/S070 Review51 Approval52
Medtronic Consulta D224TRK, Maximo II D284TRK, Concerto II D274TRK, Protecta XT CRT-D D314TRG, Protecta CRT-D D334TRG P010031/S252 Review53 Approval54
Medtronic Model 9986 Desklop/BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer P010031/S228 Review55 Approval56
InSync II Marquis Model 7289; InSync III Marquis Model7279; InSync Sentry Models 7292, 7299; InSync Maximo Models 7303, 7304; Concerto Models C154DWK, C164AWK; Concerto II Model D274TRK; Consulta Model D224TRK; Maximo II Model D284TRK P010031/S198 Review57 Approval58
Protecta XT CRT-D, Model D314TRG and Protecta'” CRT-D, Model D334TRG Implantable Cardioverter Defibrillators with Cardiac Rcsynchronization, P010031/S171 Review59 Approval60
Consulta™ D224TRK, Concerto II D274TRK, and Maximo II D284TRK ICDs with Cardiac Resynchronization Therapy (CRT-D) P010031/S150 Review61 Approval62
LifeVest Wearable Defibrillator WCD 4000 P010030/S023 Review63 Approval64
Medtronic Model 9986 Desklop/BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer P010015/S107 Review65 Approval66
InSync CRT-P Model 8040; InSync III CRT-P Model 8042 P010015/S086 Review67 Approval68
Consulta CRT-P C4TR01 and Synera CRT-P C2TR01 Implantable Pulse Generator with Cardiac Resynchroization, Software Model 9995 (version 7.3). CareLink Monitor Model 2490G, and Model 2491 DDMA P010015/S084 Review69 Approval70
TELIGEN ICD Models E103, E111, E102, and E110; COGNIS CRT-D Models N120, N118, and N119 P010012/S212 Review71 Approval72
Renamic Programmer and software version PSW 1004.U P000009/S042 Review73 Approval74
Evia/Entovis Pulse Generators P000009/S040 Review75 Approval76
Evia/Entovis Pulse Generators P000009/S035 Review77 Approval78
Floseal Hemostatic Matrix 5ml/10ml Kit P990009/S025 Review79 Approval80
SURGIFLO Hemostatic Matrix/SURGIFLO Hemostatic Matrix Kit with Thrombin P990004/S019 Review81 Approval82
Medtronic Model 9986 Desklop/BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer P990001/S082 Review83 Approval84
Vitatron DA+ C Series an T Series IPG Models C20A1, C60A1, C20A3, C60A3, T20A1, T60A1; Jade II, Topaz II, Vita IPG Models: 220, 520, 522, 310 P990001/S068 Review85 Approval86
Medtronic Model 9986 Desklop/BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer P980050/S057 Review87 Approval88
Paradym DR model 8550 and Paradym VR model 8250 P980049/S059 Review89 Approval90
Paradym VR Model 8250 and DR Model 8550 with Smartview 2.18UG1 Programmer Software P980049/S050 Review91 Approval92
Medtronic Model 9986 Desklop/BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer P980035/S200 Review93 Approval94
Adapta Models ADD01, ADDR01, ADDR03, ADDRL1, ADDRS1, ADSR01, ADSR03, ADSR06, ADVDD01; Relia Models RED01, REDR01, RES01, RESR01, REVDD01; Sensia Models SED01, SEDR01, SEDRL1, SES01, SESR01; Versa Model VEDR01; Kappa 700/600 Kappa 900/800 IPG Models KDR601, KDR603, KDR606, KDR651, KDR653, KDR721, KDR701, KDR703, KDR706, KDR731, KDR733, KD701, KD703, KD706, KVDD701, KSR701, KSR703, KSR706, KDR801, KDR803, KDR806, KDR921, KDR901, KDR906, KDR931, KDR933, KD901, KD903, KD906, KVDD901, KSR901, KSR903, KSR906; EnPulse IPG Models E2DR21, E2D31, E2D33, E2DR01, E2DR01, E2DR03, E2DR06, E2D01, E2D03, E2VDD01, E2SR01,E2SR03, E2SR06; Sigma IPG Models: SDR303, SDR306, SDR203, SD303, SD203, SVDD303, SSR303, SSR306, SSR203, SS303, SS203, SS103, SS106, SVV1103, DR353, SR353, VDD353 P980035/S168 Review95 Approval96
Entrust ICD Family Model Numbers: D153ATG, D153VRC, D154ATG, D154VRC, D154DRG P980035/S166 Review97 Approval98
XC202 Ceramic Capacitor EnRhythm Model P1501DR; Adapta IPG (DR/SR/VDD) Models ADD01, ADDR01, ADDR03, ADDR06, ADDRL1; Versa DR IPG Model VEDR01; Sensia IPG (D/DR/S/SR) SED01, SEDRL1, SES01, SEDR01, SESR01; and Relia IPG (D/DR/S/SR/VDD) Models RED01, REDR01, RES01, RESR01, REVDD01 P980035/S153 Review99 Approval100
Adapta, Versa, Sensia and Relia Implantable Pulse Generators P980035/S150 Review101 Approval102
Advisa™ DR A4DR01 Implantable Pulse Generator and Model 9995 Application Software v7.3 P980035/S134 Review103 Approval104
Linox Smart Steroid-Eluting Dual Coil ICD Leads P980023/S038 Review105 Approval106
Medtronic Secura D224DRG/D224VRC, Maximo II D284DRG/D284VRC, Virtuoso II D274DRG/D274VRC, Protecta XT DR D314DRG, Protecta DR D334DRG, Protecta XT VR D314VRG, Protecta VR D334VRG P980016/S298 Review107 Approval108
Medtronic Model 9986 Desklop/BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer P980016/S273 Review109 Approval110
Marquis DR Model 7274; Marquis Models 7230Cx, 7230B, and 7230E; Maximo DR Model 7278; Maximo VR Models 7232Cx, 7232B, and 7232B; Intrinsic 30/Intrinsic Models 7287 and 7288; EnTrust Models D154VRC, D154DRG; Maximo II Models D284DRG, D284VRC; Virtuoso DR Models D154AWG, D154VWC; EnTrust Models D153ATG, D153DRG, D153VRC, D154ATG; Virtuoso II Models D274DRG, D274VRC; Secura Models D224DRG, D224VRC P980016/S240 Review111 Approval112
Enrythm IPG Model Number: P150DR P980016/S237 Review113 Approval114
Protecta XT DR, Model D3 14DRG; Protectar XT VR, Model D3 14VRG; Protecta DR, Model D334DRG; and Protect.T VR, Model D334VRG Implantable Cardiovcrtcr Defibrillators Model SW009 Application Software vl.O Systems P980016/S211 Review115 Approval116
Secura™ DR/VR D224DRG / D224VRC, Virtuoso II DR/VR D274DRG / D274VRC and Maximo® II DR/VR D284DRG/D284VRC Implantable Cardioverter Defibrillators (ICDs) P980016/S187 Review117 Approval118
Microny Family of Pacemakers P970013/S040 Review119 Approval120
Microny Family of Pacemakers P970013/S038 Review121 Approval122
Model 3330 Version 11.1 Software for the Model 3650 Merlin Patient Care System P970013/S034 Review123 Approval124
Medtronic Model 9986 Desklop/BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer P970012/S081 Review125 Approval126
Kappa 400 IPG Models KDR401, KDR403, KSR401, KSR403 P970012/S068 Review127 Approval128
TELIGEN ICD Models E103, E111, E102, and E110; COGNIS CRT-D Models N120, N118, and N119 P960040/S198 Review129 Approval130
OptiSense Model 1999 Right Atrial Lead P960013/S057 Review131 Approval132
Tendril STS Model 1988TC Lead P960013/S054 Review133 Approval134
Evia DR 359 524; Evia DR-T 359 529; Evia SR 359 531; Evia SR-T 359 533; Entovis DR 365 461; Entovis DR-T 365 463; Entovis SR 365 465; Entovis SR-T 365 467; Estella DR 371 205; Estella DR-T 371 207; Estella SR 371 209;                Estella SR-T 371 200; Ecuro DR 375 437; Ecuro DR-T 375 439; Ecuro SR 375 433; Ecuro SR-T 375 435; Effecta D 375 429; Effecta DR 371 199; Effecta S 375 431; Effecta SR 371 202 P950037/S091 Review135 Approval136
Renamic Programmer and software version PSW 1004.U P950037/S089 Review137 Approval138
Reliaty/Model 3145 Family of Pacing System Analyzers P950037/S088 Review139 Approval140
Evia/Entovis Pulse Generators P950037/S083 Review141 Approval142
Reliaty/Model 3145 Pacing System Analyzer P950037/S079 Review143 Approval144
Evia/Entovis Pulse Generators P950037/S072 Review145 Approval146
Durata and 7F lead families P950022/S069 Review147 Approval148
Medtronic Model 9986 Desklop/BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer P930022/S012 Review149 Approval150
Endotak Reliance 4-Site Lead Models 0262, 0263, 0265, 0266
Endotak Reliance 4-Site Lead Models 0272, 0273, 0275, 0276
Endotak Reliance 4-Site Lead Models 0282, 0283, 0285, 0286
Endotak Reliance 4-Site Lead Models 0292, 0293, 0295, 0296
4-Site Terminal Tool Model 7001
Lead Cap Kit Model 7007
4-Site Lead Pulling Tip Model 7006		 P910073/S077 Review151 Approval152
Cadence Family of ICDs P910023/S264 Review153 Approval154
Cadence/Current/Fortify Family of ICDs P910023/S257 Review155 Approval156
Cadence Family of ICDs P910023/S254 Review157 Approval158
Model 3330 Version 11.1 Software for the Model 3650 Merlin Patient Care System P910023/S236 Review159 Approval160
Fortify VR/DR Models CD1231-40, CD1231-40Q, CD2231-40, and CD2231-40Q P910023/S226 Review161 Approval162
Cadence ICD System P910023/S215 Review163 Approval164
Medtronic Model 9986 Desklop/BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer P900061/S098 Review165 Approval166
Medtronic Model 9986 Desklop/BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer P890003/S211 Review167 Approval168
Application Software Model SW007 for Reveal ICM/Patient Assistant, Carelink Home Monitor an CardioSight Monitor P890003/S209 Review169 Approval170
Multiple AVX Vendor Changes for Medtronic Implantable Devices P890003/S192 Review171 Approval172
Carelink DDMA Software, Carelink Monitor Model Numbers 2491, 2490G P890003/S191 Review173 Approval174
Consulta CRT-P C4TR01 and Synera CRT-P C2TR01 Implantable Pulse Generator with Cardiac Resynchroization, Software Model 9995 (version 7.3). CareLink Monitor Model 2490G, and Model 2491 DDMA P890003/S189 Review175 Approval176
Carelink Monitor, Model 2490C, CardioSight® Reader, Model 2020A, DDMA Model 2491 P890003/S177 Review177 Approval178
CareLink Monitor Model 2490G, CardioSight® Reader Model 2020A, and Model 2491 Device Data Management Application (DDMA) P890003/S169 Review179 Approval180
Affinity/Integrity/Victory/Zephyr/Accent Family of Pacemakers P880086/S203 Review181 Approval182
Affinity/Integrity/Victory Family of Pacemakers P880086/S195 Review183 Approval184
Model 3330 Version 11.1 Software for the Model 3650 Merlin Patient Care System P880086/S189 Review185 Approval186
Sensolog/Dialog/Regency Family of Pacemakers P880006/S071 Review187 Approval188
Sensolog/Dialog/Regency Family of Pacemakers P880006/S070 Review189 Approval190
Model 3330 Version 11.1 Software for the Model 3650 Merlin Patient Care System P880006/S067 Review191 Approval192
Medtronic Model 9986 Desklop/BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer P850051/S074 Review193 Approval194
Lead Tunneler Model 6888 P830060/S062 Review195 Approval196
Medtronic Model 9986 Desklop/BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer P820003/S104 Review197 Approval198

 

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