BOSTONSCIENTIFIC

FDA Filings

This page includes the latest FDA filings for BOSTONSCIENTIFIC. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate

Latest Premarket Applications

PMAManufacturerDevice NameDate
BOSTONSCIENTIFIC
Essentio Mri Sr, Essentio Mri Dr, Essentio Mri El 2019-12-04
BOSTONSCIENTIFIC
Essentio MRI SR/DR SL, Essentio MRI DR EL, Proponent MRI SR/DR SL, Proponent MRI DR EL, Accolade MRI SR/DR SL and Accola2019-11-27
BOSTONSCIENTIFIC
MRI Pacemakers2019-10-29
BOSTONSCIENTIFIC
Essentio, Proponent, and Accolade MRI Pacemakers2019-09-24
BOSTONSCIENTIFIC
Essentio, Proponent, and Accolade MRI Pacemakers2019-09-18
BOSTONSCIENTIFIC
Accolade MRI Pacemakers2019-06-21
BOSTONSCIENTIFIC
Pacemaker s: INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI2019-06-10
BOSTONSCIENTIFIC
Ingevity Leads2019-05-23
BOSTONSCIENTIFIC
Accessory Stylet STR 0.013 45CM, Accessory Stylet STR 0.013 52CM,Accessory Stylet STR 0.013 59CM, Accessory Stylet LTPR2019-04-08
BOSTONSCIENTIFIC
INGEVITY Distal Tip Laser Weld Process2019-03-14
BOSTONSCIENTIFIC
Ingevity MRI2019-02-28
BOSTONSCIENTIFIC
INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI (Pacemaker s)2019-02-22
BOSTONSCIENTIFIC
Accolade MRI Pacemakers2019-02-19
BOSTONSCIENTIFIC
Ingevity Lead Family (passive fixation models)2019-01-10
BOSTONSCIENTIFIC
INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI2018-11-16
BOSTONSCIENTIFIC
INGEVITY Leads2018-11-09
BOSTONSCIENTIFIC
INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers, INGEVITY MRI Lead, Slit Sutu2018-07-27
BOSTONSCIENTIFIC
Ingevity, Ingevity MRI2018-07-26
BOSTONSCIENTIFIC
ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI2018-07-17
BOSTONSCIENTIFIC
INGEVITY MRI Passive Fixation Leads, INGEVITY non-MRI Passive Fixation Leads2018-07-05
BOSTONSCIENTIFIC
Ingevity Lead Family2018-05-16
BOSTONSCIENTIFIC
Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead2018-04-25
BOSTONSCIENTIFIC
Accolade MRI, Essentio MRI, Proponent MRI2018-04-11
BOSTONSCIENTIFIC
INGEVITY MRI Active Fixation Lead Models2018-04-05
BOSTONSCIENTIFIC
Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, Accolade MRI2018-03-26
BOSTONSCIENTIFIC
Accolade MRI Pacemakers: ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI2018-03-12
BOSTONSCIENTIFIC
ESSENTIO; PROPONENT; ACCOLADE MRI2018-02-08
BOSTONSCIENTIFIC
Essentio MRI, Proponent MRI, Accolade MRI Pacemakers2018-02-02
BOSTONSCIENTIFIC
Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead2018-01-07
BOSTONSCIENTIFIC
Accolade MRI, Essentio MRI, Formio MRI, Ingenio MRI, Proponent MRI, Vitalio MRI2017-12-19

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate

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