| Pacemaker Devices (P150012/S131) | Boston Scientific | 2022-12-20 |
| LATITUDE NXT Release 7.1.5 (P910077/S188) | Boston Scientific | 2022-12-20 |
| INGEVITY+ and INGEVITY MRI (P150012/S137) | Boston Scientific | 2022-12-15 |
| INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR, MOMENTUM EL ICD VR, MOMENTUM EL (P960040/S488) | Boston Scientific | 2022-12-14 |
| LATITUDE Wave Communicator Model 6290 (P910077/S190) | Boston Scientific | 2022-12-14 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL (P150012/S136) | Boston Scientific | 2022-12-14 |
| MRI Pacemakers (P150012/S132) | Boston Scientific | 2022-12-12 |
| Accolade Family of Devices Pacemakers, and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps) (P150012/S134) | Boston Scientific | 2022-12-12 |
| Implantable Cardioverter Defibrillator (ICD) (P960040/S484) | Boston Scientific | 2022-12-12 |
| Bi-Directional Torque Wrench Model 6628 (P960040/S482) | Boston Scientific | 2022-11-15 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S137) | Boston Scientific | 2022-11-15 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S129) | Boston Scientific | 2022-11-08 |
| Ventak® PRX Pulse Generator (P910077/S189) | Boston Scientific | 2022-11-02 |
| Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems (P830060/S088) | Boston Scientific | 2022-11-02 |
| Imagerade MR Conditional Pacing System and Ingevity Pacing/Sense Lead (P150012/S135) | Boston Scientific | 2022-11-02 |
| Thinline Endocardial Pacing Leads (P960004/S101) | Boston Scientific | 2022-11-02 |
| Ventak® P2 System (P930035/S033) | Boston Scientific | 2022-11-02 |
| Sweet TIP® RX Steroid Eluting Lead (P960006/S055) | Boston Scientific | 2022-11-02 |
| Endotak Lead System (P910073/S170) | Boston Scientific | 2022-11-02 |
| PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI DR (P150012/S133) | Boston Scientific | 2022-10-28 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM (P960040/S486) | Boston Scientific | 2022-10-28 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM (P960040/S487) | Boston Scientific | 2022-10-14 |
| REALIANCE 4-SITE Family of Defibrillation Leads (P910073/S169) | Boston Scientific | 2022-10-14 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT MRI SR, PROPONENT MRI DR, PROPONENT MRI EL DR, ACCOLAD (P150012/S130) | Boston Scientific | 2022-09-27 |
| ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD (P960040/S481) | Boston Scientific | 2022-09-27 |
| BLAZER II XP Temperature Ablation Catheter, BLAZER PRIME XP Temperature Ablation Catheter, INTELLATIP MIFI XP Tempe (P020025/S136) | Boston Scientific | 2022-09-21 |
| INGEVITY+ Active Fixation Pace/Sense Lead (P150012/S125) | Boston Scientific | 2022-08-29 |
| RESONATE HF, RESONATE EL, MOMENTUM EL, VIGILIANT EL, PERCIVA HF, PERCIVA (P960040/S476) | Boston Scientific | 2022-08-26 |
| Fineline II Sterox, Sterox EZ pace / sense leads (P960004/S100) | Boston Scientific | 2022-07-28 |
| PG Essentio MRI SR SL, PG Essentio MRI DR SL, PG Essentio MRI DR EL, PG Proponent MRI SR SL, PG Proponent MRI DR EL, PG (P150012/S127) | Boston Scientific | 2022-07-27 |
| Ingevity MRI pace/sense lead, Ingevity+ MRI pace/sense lead (P150012/S128) | Boston Scientific | 2022-07-25 |
| ICD Inogen VR, ICD Dynagen VR, ICD Dynagen DR, Momentum EL ICD VR, Momentum EL ICD DR, Vigilant EL ICD VR, Vigilant EL I (P960040/S480) | Boston Scientific | 2022-07-22 |
| PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI DR (P150012/S126) | Boston Scientific | 2022-07-13 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD ORIGEN VR, ICD ORIGEN DR (P960040/S479) | Boston Scientific | 2022-07-13 |
| ICD INOGEN VR DF4, ICD INOGEN VR DF1/IS1, ICD INOGEN DR DF4/IS1, ICD INOGEN DR DF1/IS1, ICD DYNAGEN VR DF1/IS1, ICD DYNA (P960040/S478) | Boston Scientific | 2022-06-21 |
| Tachy DF4 header core (P960040/S477) | Boston Scientific | 2022-04-13 |
| LD BG1 TN STR MRI IS1, LD BG1 TN J MRI IS1, LD BG1 PFRET STR MRI IS1, LD INGEVITY PLUS AF IS1 (P150012/S124) | Boston Scientific | 2022-03-29 |
| INGEVITY MRI pace/sense lead (P150012/S123) | Boston Scientific | 2022-03-08 |
| FINELINE II pace/sense lead (P960004/S099) | Boston Scientific | 2022-03-08 |
| RELIANCE 4-FRONT defibrillation pace/sense lead, ENDOTAK RELIANCE defibrillation pace/sense lead (P910073/S168) | Boston Scientific | 2022-03-08 |
| Ventak AV Acid VENTAK Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defibrillator System (P960040/S475) | Boston Scientific | 2022-03-04 |
| Blazer II XP Catheter, Blazer Prime XP Catheter, IntellaTip MiFi XP Catheter, IntellaNav XP Catheter and IntellaNav MiFi (P020025/S135) | Boston Scientific | 2022-02-25 |
| Pacemaker Devices (P150012/S120) | Boston Scientific | 2022-02-24 |
| Model 3300 LATITUDE Programming System (P910077/S187) | Boston Scientific | 2022-02-24 |
| ICD Devices (P960040/S473) | Boston Scientific | 2022-02-24 |
| Blazer II XP Temperature Ablation Catheter, Blazer Prime XP Temperature Ablation Catheter, IntellaTip MiFi XP Tempera (P020025/S134) | Boston Scientific | 2022-02-22 |
| RELIANCE 4-FRONT (P910073/S165) | Boston Scientific | 2021-12-23 |
| L110 ESSENTIO MRI SR, L111 ESSENTIO MRI DR, L131 ESSENTIO MRI EL DR, L210 PROPONENT, L211 PROPONENT, L231 PROPONENT, (P150012/S121) | Boston Scientific | 2021-12-23 |
| ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI (P960040/S474) | Boston Scientific | 2021-12-21 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL (P150012/S122) | Boston Scientific | 2021-12-21 |
| INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S116) | Boston Scientific | 2021-11-30 |
| LATITUDE Programming System (P910077/S186) | Boston Scientific | 2021-11-30 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA (P960040/S468) | Boston Scientific | 2021-11-30 |
| ESSENTIO MRI SR; ESSENTIO MRI DR; ESSENTIO MRI EL DR; PROPONENT MRI SR ; PROPONENT MRI DR; PROPONENT MRI EL DR; ACCOLA (P150012/S119) | Boston Scientific | 2021-10-21 |
| ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR,DYNAGEN MINI ICD D (P960040/S472) | Boston Scientific | 2021-10-21 |
| Resonate, Momentum, Vigilant, Perciva, Autogen, Dynagen, Inogen, Origen Implantable Cardioverter Defibrillators (P960040/S459) | Boston Scientific | 2021-10-07 |
| Resonate family of CRT-D's (P960040/S466) | Boston Scientific | 2021-10-07 |
| Ventak Av Aicd Ventak Prizm Dr/Vr, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defribillator System (P960004/S098) | Boston Scientific | 2021-10-06 |
| Endoktak Lead System (P910073/S167) | Boston Scientific | 2021-10-06 |
| Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems (P830060/S087) | Boston Scientific | 2021-10-04 |
| Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead (P150012/S118) | Boston Scientific | 2021-10-04 |
| Thinline Endocardial Pacing Leads (P960004/S097) | Boston Scientific | 2021-10-04 |
| Endotak Lead System (P910073/S166) | Boston Scientific | 2021-10-04 |
| Sweet Tip (R) Rx Steroid Eluting Lead (P960006/S054) | Boston Scientific | 2021-10-04 |
| THINLINE / FINELINE Family of Endocardial Pacing Leads (P960004/S095) | Boston Scientific | 2021-09-24 |
| FNLN2 SXP BP, FNLN2 SXP PF BP, FNLN2 SX PF BP, FNLN2 SXP J BP, (P960004/S096) | Boston Scientific | 2021-09-24 |
| SWEET TIP Rx, SWEET PICOTIP Rx, and FLEXTEND (P960006/S053) | Boston Scientific | 2021-09-24 |
| ORIGEN VR, ORIGEN DR, INOGEN DR, INOGEN VR, DYNAGEN VR, DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL (P960040/S470) | Boston Scientific | 2021-09-24 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, PROPONENT MRI SR, PROPONENT MRI DR, ACCOLADE MRI SR, ACCOLADE MRI DR, INGEVITY PLUS AF (P150012/S117) | Boston Scientific | 2021-09-24 |
| REL S, REL, REL SEZ, REL EZ DUAL COIL, REL SG, REL G, SEN (P910073/S164) | Boston Scientific | 2021-09-24 |
| INGEVITY and INGEVITY MRI Leads and Accessories; VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI (P150012/S115) | Boston Scientific | 2021-09-24 |
| ENDOTAK Lead System (P910073/S163) | Boston Scientific | 2021-09-24 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN (P960040/S469) | Boston Scientific | 2021-09-20 |
| INGENIO MRI, VITALIO MRI, VORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S114) | Boston Scientific | 2021-09-17 |
| LATITUDE NXT Remote Patient Management System, LATITUDEWave Communicator, LATITUDE Consult Communicator, LATITUDE NX (P910077/S185) | Boston Scientific | 2021-09-17 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA (P960040/S465) | Boston Scientific | 2021-09-17 |
| IntellaNav MiFi XP, IntellaNav XP (P020025/S133) | Boston Scientific | 2021-09-07 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S112) | Boston Scientific | 2021-09-03 |
| IntellaTip MiFi Filter Module, IntellaTip MiFi Reference Cable, EGM Cable, Maestro 4000 Footswitch (P020025/S132) | Boston Scientific | 2021-08-17 |
| Blazer II XP Temperature Ablation Catheter, Blazer Prime XP Temperature Ablation Catheter, IntellaTip MiFi XP Temperatur (P020025/S129) | Boston Scientific | 2021-08-05 |
| VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S467) | Boston Scientific | 2021-07-23 |
| INGEVITY Passive Fixation leads (P150012/S113) | Boston Scientific | 2021-07-14 |
| RELIANCE 4-FRONT Steroid-eluting Pace/Sense and Defibrillation Lead (P910073/S162) | Boston Scientific | 2021-06-08 |
| VENTAK(R) P2 SYSTEM (P930035/S032) | Boston Scientific | 2021-05-10 |
| IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S111) | Boston Scientific | 2021-05-10 |
| THINLINE ENDOCARDIAL PACING LEADS (P960004/S094) | Boston Scientific | 2021-05-10 |
| VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS (P830060/S086) | Boston Scientific | 2021-05-10 |
| VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR (P910077/S184) | Boston Scientific | 2021-05-10 |
| SWEET TIP(R) RX STEROID ELUTING LEAD (P960006/S052) | Boston Scientific | 2021-05-10 |
| ENDOTAK LEAD SYSTEM (P910073/S161) | Boston Scientific | 2021-05-10 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL DR (P150012/S110) | Boston Scientific | 2021-05-06 |
| ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR (P960040/S464) | Boston Scientific | 2021-05-06 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL DR (P150012/S109) | Boston Scientific | 2021-04-30 |
| ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR (P960040/S463) | Boston Scientific | 2021-04-30 |
| Implantable Pulse Generator Test Magnet (P830060/S084) | Boston Scientific | 2021-04-16 |
| IntellaTip MiFi Filter Module and IntellaTip MiFi Reference Cable (P020025/S130) | Boston Scientific | 2021-04-08 |
| COSMOS System (P830026/S083) | Boston Scientific | 2021-04-02 |
| SELUTE Lead System (P950001/S029) | Boston Scientific | 2021-04-02 |
| INGEVITY and INGEVITY MRI Leads and Accessories; VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI (P150012/S107) | Boston Scientific | 2021-04-02 |
| ENDOTAK Lead System (P910073/S160) | Boston Scientific | 2021-04-02 |