| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S056) | Boston Scientific Corporation | 2019-12-04 |
| Innova Vascular Self-Expanding Stent System (P140028/S048) | Boston Scientific Corporation | 2019-12-04 |
| VICI VENOUS STENT System (P180013/S003) | Boston Scientific Corporation | 2019-12-02 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P150003/S057) | Boston Scientific Corporation | 2019-11-26 |
| LOTUS Edge Valve System (P180029/S017) | Boston Scientific Corporation | 2019-11-21 |
| Axonics Sacral Neuromodulation System (P180046) | Boston Scientific Corporation | 2019-11-13 |
| Lotus Edge Valve System (P180029/S016) | Boston Scientific Corporation | 2019-11-12 |
| LOTUS Edge Valve System (P180029/S008) | Boston Scientific Corporation | 2019-10-30 |
| VICI VENOUS STENT System (P180013/S001) | Boston Scientific Corporation | 2019-10-30 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S130) | Boston Scientific Corporation | 2019-10-29 |
| LOTUS Edge Valve System (P180029/S015) | Boston Scientific Corporation | 2019-10-13 |
| Innova Vascular Self-Expanding Stent System (P140028/S044) | Boston Scientific Corporation | 2019-10-11 |
| EMBLEM S-ICD Electrode (P110042/S128) | Boston Scientific Corporation | 2019-10-10 |
| Wallstent Venous RP & Endoprosthesis with Unistep Plus (P980033/S056) | Boston Scientific Corporation | 2019-10-07 |
| LOTUS Edge Valve System (P180029/S013) | Boston Scientific Corporation | 2019-10-07 |
| Innova Vascular Self Expanding Stent System (P140028/S046) | Boston Scientific Corporation | 2019-10-07 |
| LOTUS Edge Valve System (P180029/S014) | Boston Scientific Corporation | 2019-10-03 |
| LOTUS Edge Valve System (P180029/S012) | Boston Scientific Corporation | 2019-09-26 |
| Innova Vascular Self-Expanding Stent System (P140028/S045) | Boston Scientific Corporation | 2019-09-23 |
| Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S053) | Boston Scientific Corporation | 2019-09-13 |
| Innova Self-Expanding Stent System (P140028/S042) | Boston Scientific Corporation | 2019-09-13 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) pulse generator (PG) high voltage (HV) capacitor stack (P110042/S127) | Boston Scientific Corporation | 2019-09-13 |
| Axonics Sacral Neuromodulation System (P190006) | Boston Scientific Corporation | 2019-09-06 |
| Innova Vascular Self-Expanding Stent System (P140028/S043) | Boston Scientific Corporation | 2019-09-06 |
| ENROUTE Transcarotid Stent System (P140026/S013) | Boston Scientific Corporation | 2019-09-04 |
| LOTUS Edge Valve System (P180029/S010) | Boston Scientific Corporation | 2019-08-21 |
| Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S052) | Boston Scientific Corporation | 2019-08-20 |
| LOTUS Edge Valve System (P180029/S009) | Boston Scientific Corporation | 2019-08-15 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) (P150003/S051) | Boston Scientific Corporation | 2019-08-09 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S041) | Boston Scientific Corporation | 2019-07-25 |
| EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S048) | Boston Scientific Corporation | 2019-07-25 |
| LOTUS Edge Valve System (P180029/S007) | Boston Scientific Corporation | 2019-07-25 |
| WALLSTENT ENDOPROSTHESIS (P980033/S055) | Boston Scientific Corporation | 2019-07-25 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S050) | Boston Scientific Corporation | 2019-07-25 |
| Lotus Edge Valve System (P180029/S002) | Boston Scientific Corporation | 2019-07-22 |
| ORBERA Intragastric Balloon System (P140008/S018) | Boston Scientific Corporation | 2019-07-19 |
| Lotus Edge Valve System (P180029/S005) | Boston Scientific Corporation | 2019-07-11 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S126) | Boston Scientific Corporation | 2019-07-11 |
| LOTUS Edge Valve System (P180029/S004) | Boston Scientific Corporation | 2019-06-22 |
| LOTUS Edge Valve System (P180029/S006) | Boston Scientific Corporation | 2019-06-19 |
| Innova Vasculaar Self-Expanding Stent System (P140028/S040) | Boston Scientific Corporation | 2019-06-18 |
| Express LD Premounted Iliac Stent System (ELD) (P090003/S047) | Boston Scientific Corporation | 2019-06-18 |
| Synergy Everolimus-Eluting Platinum Chromium Coronaray Stent System (P150003/S047) | Boston Scientific Corporation | 2019-06-18 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S049) | Boston Scientific Corporation | 2019-06-14 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S048) | Boston Scientific Corporation | 2019-06-11 |
| Subcutaneous ICD Devices: EMBLEM (P110042/S125) | Boston Scientific Corporation | 2019-06-10 |
| LOTUS Edge Valve System (P180029/S001) | Boston Scientific Corporation | 2019-06-04 |
| ORBERA Intragastric Balloon System (P140008/S017) | Boston Scientific Corporation | 2019-06-03 |
| Wallstent Venous Endoprosthesis with UNISTEP Plus (P980033/S054) | Boston Scientific Corporation | 2019-05-30 |
| Express LD Iliac Premounted Stent System (P090003/S046) | Boston Scientific Corporation | 2019-05-30 |
| EMBLEM Programmer (P110042/S123) | Boston Scientific Corporation | 2019-05-21 |
| lnnova Self-Expanding Stent System (P140028/S039) | Boston Scientific Corporation | 2019-05-09 |
| VICI VENOUS STENT System (P180013) | Boston Scientific Corporation | 2019-05-02 |
| ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S012) | Boston Scientific Corporation | 2019-04-30 |
| LOTUS Edge Valve System (P180029) | Boston Scientific Corporation | 2019-04-23 |
| Wallstent Venous Endoprosthesis with UNISTEP Plus (P980033/S053) | Boston Scientific Corporation | 2019-04-17 |
| Express LD Iliac Premounted Stent System (P090003/S045) | Boston Scientific Corporation | 2019-04-17 |
| Emblem S-ICD Electrode 45cm (P110042/S124) | Boston Scientific Corporation | 2019-04-08 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S043) | Boston Scientific Corporation | 2019-03-29 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) plus generator (PG) devices (P110042/S122) | Boston Scientific Corporation | 2019-03-27 |
| Innova Vascular Self-Expanding Stent System (P140028/S037) | Boston Scientific Corporation | 2019-03-04 |
| Innova Vascular Self-Expanding Stent System (P140028/S038) | Boston Scientific Corporation | 2019-03-04 |
| Emblem S-ICD, Electrode (P110042/S120) | Boston Scientific Corporation | 2019-02-28 |
| EMBLEM (Subcutaneous ICD Devices) (P110042/S119) | Boston Scientific Corporation | 2019-02-22 |
| SYNERGY Everolimus Eluting Platinum Chromium Coronary Stent System Monorail (MR) and Over-The-Wire (OTW) (P150003/S046) | Boston Scientific Corporation | 2019-02-14 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) EMBLEM S-ICD/MRI S-ICD (P110042/S121) | Boston Scientific Corporation | 2019-01-23 |
| Innova Vascular Self-Expanding Stent System (P140028/S036) | Boston Scientific Corporation | 2019-01-10 |
| Wallstent (Venous) Endoprosthesis with Unisteo Plus Delivery System (P980033/S051) | Boston Scientific Corporation | 2018-12-21 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S045) | Boston Scientific Corporation | 2018-12-20 |
| Enroute Transcarotid Stent System (P140026/S011) | Boston Scientific Corporation | 2018-12-20 |
| Wallstent (Venous) Endoprosthesis with Unistep Plus Delivery System (P980033/S052) | Boston Scientific Corporation | 2018-12-17 |
| Innova Self-Expanding Stent System (P140028/S034) | Boston Scientific Corporation | 2018-12-14 |
| Synergy Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S044) | Boston Scientific Corporation | 2018-12-14 |
| Innova Vascular Self-Expanding Stent System (P140028/S035) | Boston Scientific Corporation | 2018-12-11 |
| EMBLEM S-ICD Pulse Generator; EMBLEM MRI S-ICD Pulse Generator (P110042/S117) | Boston Scientific Corporation | 2018-12-06 |
| EMBLEM S-ICD PG Models A209 and A219 (P110042/S118) | Boston Scientific Corporation | 2018-11-29 |
| Orbera Intragastric Balloon (P140008/S014) | Boston Scientific Corporation | 2018-11-28 |
| EMBLEM, EMBLEM MRI (P110042/S116) | Boston Scientific Corporation | 2018-11-16 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Electrode (P110042/S114) | Boston Scientific Corporation | 2018-10-24 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S039) | Boston Scientific Corporation | 2018-10-18 |
| Innova Vascular Self-Expanding Stent System (P140028/S033) | Boston Scientific Corporation | 2018-10-18 |
| Express LD Iliac Premounted System (P090003/S044) | Boston Scientific Corporation | 2018-10-10 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S115) | Boston Scientific Corporation | 2018-10-10 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-wire) (P150003/S042) | Boston Scientific Corporation | 2018-09-19 |
| EMBLEM S-ICD & EMBLEM MRI S-ICD (P110042/S113) | Boston Scientific Corporation | 2018-09-05 |
| ORBERA Intragastric Balloon System (P140008/S008) | Boston Scientific Corporation | 2018-09-04 |
| Emblem S-ICD, Emblem MRI S-ICD (P110042/S112) | Boston Scientific Corporation | 2018-09-04 |
| SYNERGY Everolimus-Eluting Platinum Chrominum Coronary Stent System (P150003/S036) | Boston Scientific Corporation | 2018-08-30 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S041) | Boston Scientific Corporation | 2018-08-22 |
| ORBERA Intragastric Balloon (P140008/S013) | Boston Scientific Corporation | 2018-08-17 |
| Enroute Transcarotid Stent System (P140026/S010) | Boston Scientific Corporation | 2018-08-16 |
| Emblem S-ICD Electrode (P110042/S111) | Boston Scientific Corporation | 2018-07-26 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S040) | Boston Scientific Corporation | 2018-06-28 |
| Innova Self-Expanding Stent System (P140028/S032) | Boston Scientific Corporation | 2018-06-28 |
| EMBLEM S-ICD Pulse Generator (PG), EMBLEM MRI S-ICD Pulse Generator (PG) (P110042/S110) | Boston Scientific Corporation | 2018-06-19 |
| S-ICD Pulse Generator, Emblem S-ICD, Emblem MRI S-ICD (P110042/S108) | Boston Scientific Corporation | 2018-06-01 |
| ReShape Integrated Dual Balloon System (P140012/S013) | Boston Scientific Corporation | 2018-05-31 |
| Orbera Intragastric Balloon System (P140008/S012) | Boston Scientific Corporation | 2018-05-31 |
| ReShape Integrated Dual Balloon System (P140012/S012) | Boston Scientific Corporation | 2018-05-30 |
| EMBLEM MRI S-CD/ EMBLEM S-CD Pulse Generator (PG) (P110042/S107) | Boston Scientific Corporation | 2018-05-15 |