Bostonscientific

FDA Filings

This page includes the latest FDA filings for Bostonscientific. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device Company	Device	Date
PMA P150012S121 BOSTONSCIENTIFIC	L110 ESSENTIO™ MRI SR, L111 ESSENTIO™ MRI DR, L131 ESSENTIO™ MRI EL DR, L210 PROPONENT, L211 PROPONENT, L231 PROPONENT,	2021-12-23
PMA P150012S122 BOSTONSCIENTIFIC	ESSENTIO™ MRI SR, ESSENTIO™ MRI DR, ESSENTIO™ MRI EL DR, PROPONENT, ACCOLADE™ MRI SR, ACCOLADE™ MRI DR, ACCOLADE™ MRI EL	2021-12-21
PMA P150012S119 BOSTONSCIENTIFIC	ESSENTIO™ MRI SR; ESSENTIO MRI DR; ESSENTIO MRI EL DR; PROPONENT™ MRI SR ; PROPONENT MRI DR; PROPONENT MRI EL DR; ACCOLA	2021-10-21
PMA P150012S118 BOSTONSCIENTIFIC	Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead	2021-10-04
PMA P150012S117 BOSTONSCIENTIFIC	ESSENTIO MRI SR, ESSENTIO MRI DR, PROPONENT MRI SR, PROPONENT MRI DR, ACCOLADE MRI SR, ACCOLADE MRI DR, INGEVITY PLUS AF	2021-09-24
PMA P150012S115 BOSTONSCIENTIFIC	INGEVITY and INGEVITY MRI Leads and Accessories; VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI	2021-09-24
PMA P150012S114 BOSTONSCIENTIFIC	INGENIO MRI, VITALIO MRI, VORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI	2021-09-17
PMA P150012S113 BOSTONSCIENTIFIC	INGEVITY Passive Fixation leads	2021-07-14
PMA P150012S111 BOSTONSCIENTIFIC	IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD	2021-05-10
PMA P150012S110 BOSTONSCIENTIFIC	ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL DR	2021-05-06
PMA P150012S109 BOSTONSCIENTIFIC	ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL DR	2021-04-30
PMA P150012S108 BOSTONSCIENTIFIC	INGEVITY MRI Pace/Sense Leads	2021-04-02
PMA P150012S107 BOSTONSCIENTIFIC	INGEVITY and INGEVITY MRI Leads and Accessories; VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI	2021-04-02
PMA P150012S106 BOSTONSCIENTIFIC	INGEVITY™ non-MRI Lead Passive Fixation, Preformed Atrial J, INGEVITY™ non-MRI Lead Passive Fixation, Ventricular, INGEV	2021-01-13
PMA P150012S105 BOSTONSCIENTIFIC	ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, and ACCOLADE MRI EL D	2020-12-11
PMA P150012S103 BOSTONSCIENTIFIC	ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI	2020-11-16
PMA P150012S102 BOSTONSCIENTIFIC	PG ACCOLADE MRI DR, PG ACCOLADE MRI SR, PG ESSENTIO MRI DR, PG ESSENTIO MRI SR, PG PROPONENT MRI DR, and PG PROPONENT M	2020-10-22
PMA P150012S100 BOSTONSCIENTIFIC	ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI Pacemakers	2020-10-16
PMA P150012S101 BOSTONSCIENTIFIC	PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI D	2020-10-01
PMA P150012S098 BOSTONSCIENTIFIC	ESSENTIO, PROPONENT, ACCOLADE - MRI Pacemakers	2020-09-03
PMA P150012S097 BOSTONSCIENTIFIC	IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD	2020-08-03
PMA P150012S095 BOSTONSCIENTIFIC	Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead	2020-06-19
PMA P150012S094 BOSTONSCIENTIFIC	INGEVITY lead family	2020-05-04
PMA P150012S093 BOSTONSCIENTIFIC	INGEVITY MRI Lead and INGEVITY non-MRI Lead	2020-04-16
PMA P150012S091 BOSTONSCIENTIFIC	ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, and ACCOLADE MRI EL D	2020-03-17
PMA P150012S090 BOSTONSCIENTIFIC	PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, and PG ACCOLADE MR	2020-03-05
PMA P150012S089 BOSTONSCIENTIFIC	PG ESSENTION MRI SR/DR SL, PG ESSENTIO DR EL, PG ESSENTIO MRI DR EL, PG PROPONENT MRI SR/DR/ SL, PG PROPONENT MRI DR EL,	2020-01-28
PMA P150012S087 BOSTONSCIENTIFIC	Essentio MRI SR, Essentio MRI DR, Essentio MRI EL DR, Proponent, Accolade MRI SR, Accolade MRI DR and Accolade MRI EL DR	2019-12-04
PMA P150012S086 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 Accola	2019-11-27
PMA P150012S084 BOSTONSCIENTIFIC	MRI Pacemakers	2019-10-29
PMA P150012S082 BOSTONSCIENTIFIC	Essentio, Proponent, and Accolade MRI Pacemakers	2019-09-24
PMA P150012S080 BOSTONSCIENTIFIC	Essentio, Proponent, and Accolade MRI Pacemakers	2019-09-18
PMA P150012S079 BOSTONSCIENTIFIC	Accolade MRI Pacemakers	2019-06-21
PMA P150012S075 BOSTONSCIENTIFIC	Pacemaker s: INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI	2019-06-10
PMA P150012S077 BOSTONSCIENTIFIC	Ingevity Leads	2019-05-23
PMA P150012S074 BOSTONSCIENTIFIC	Accessory Stylet STR 0.013 45CM, Accessory Stylet STR 0.013 52CM,Accessory Stylet STR 0.013 59CM, Accessory Stylet LTPR	2019-04-08
PMA P150012S072 BOSTONSCIENTIFIC	INGEVITY Distal Tip Laser Weld Process	2019-03-14
PMA P150012S070 BOSTONSCIENTIFIC	Ingevity MRI	2019-02-28
PMA P150012S067 BOSTONSCIENTIFIC	INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI (Pacemaker s)	2019-02-22
PMA P150012S071 BOSTONSCIENTIFIC	Accolade MRI Pacemakers	2019-02-19
PMA P150012S069 BOSTONSCIENTIFIC	Ingevity Lead Family (passive fixation models)	2019-01-10
PMA P150012S066 BOSTONSCIENTIFIC	INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI	2018-11-16
PMA P150012S065 BOSTONSCIENTIFIC	INGEVITY Leads	2018-11-09
PMA P150012S060 BOSTONSCIENTIFIC	INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers, INGEVITY MRI Lead, Slit Sutu	2018-07-27
PMA P150012S064 BOSTONSCIENTIFIC	Ingevity, Ingevity MRI	2018-07-26
PMA P150012S062 BOSTONSCIENTIFIC	ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI	2018-07-17
PMA P150012S063 BOSTONSCIENTIFIC	INGEVITY MRI Passive Fixation Leads, INGEVITY non-MRI Passive Fixation Leads	2018-07-05
PMA P150012S059 BOSTONSCIENTIFIC	Ingevity Lead Family	2018-05-16
PMA P150012S058 BOSTONSCIENTIFIC	Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead	2018-04-25
PMA P150012S055 BOSTONSCIENTIFIC	Accolade MRI, Essentio MRI, Proponent MRI	2018-04-11
PMA P150012S056 BOSTONSCIENTIFIC	INGEVITY MRI Active Fixation Lead Models	2018-04-05
PMA P150012S052 BOSTONSCIENTIFIC	Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, Accolade MRI	2018-03-26
PMA P150012S054 BOSTONSCIENTIFIC	Accolade MRI Pacemakers: ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI	2018-03-12
PMA P150012S053 BOSTONSCIENTIFIC	ESSENTIO; PROPONENT; ACCOLADE MRI	2018-02-08
PMA P150012S051 BOSTONSCIENTIFIC	Essentio MRI, Proponent MRI, Accolade MRI Pacemakers	2018-02-02
PMA P150012S044 BOSTONSCIENTIFIC	Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead	2018-01-07
PMA P150012S050 BOSTONSCIENTIFIC	Accolade MRI, Essentio MRI, Formio MRI, Ingenio MRI, Proponent MRI, Vitalio MRI	2017-12-19
PMA P150012S043 BOSTONSCIENTIFIC	IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD	2017-12-13
PMA P150012S046 BOSTONSCIENTIFIC	Accolade MRI Pacemakers: ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI	2017-12-11
PMA P150012S049 BOSTONSCIENTIFIC	ESSENTIO MRI / PROPONENT MRI /ACCOLADE MRI / Accolade MRI Pacemakers	2017-12-06
PMA P150012S048 BOSTONSCIENTIFIC	ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI, MRI Pacemakers	2017-12-06
PMA P150012S045 BOSTONSCIENTIFIC	Accolade MRI, Essentio MRI, Proponent MRI (Accolade MRI)	2017-12-01
PMA P150012S047 BOSTONSCIENTIFIC	Active Fixation INGEVITY Leads	2017-11-28
PMA P150012S041 BOSTONSCIENTIFIC	Essentio MRI, Proponent MRI, Accolade MRI - Accolade MRI Pacemakers	2017-10-26
PMA P150012S042 BOSTONSCIENTIFIC	Accolade MRI Pacemakers: ESSENTIO MRI, PROPNENT MRI, ACCOLADE MRI	2017-10-20
PMA P150012S040 BOSTONSCIENTIFIC	Essentio MRI / Proponent MRI / Accolade MRI / Accp;ade MRI Pacemakers	2017-10-18
PMA P150012S038 BOSTONSCIENTIFIC	INGEVITY Active-Fixation Non-MRI / Active-Fixation MRI	2017-10-05
PMA P150012S037 BOSTONSCIENTIFIC	Pacemakers: Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, and Accolade MRI	2017-09-25
PMA P150012S034 BOSTONSCIENTIFIC	ESSENTIO MRI / PROPONENT MRI / ACCOLADE MRI	2017-09-21
PMA P150012S032 BOSTONSCIENTIFIC	INGEVITY™ MRI Leads, Slit Suture Sleeve Accessory for INGEVITY Leads (Pacing Leads and Accessories)	2017-09-20
PMA P150012S039 BOSTONSCIENTIFIC	INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, ACCOLADE MRI, PROPONENT MRI	2017-09-11
PMA P150012S033 BOSTONSCIENTIFIC	Torque Wrench	2017-09-11
PMA P150012S036 BOSTONSCIENTIFIC	Pacemakers: ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI	2017-08-30
PMA P150012S035 BOSTONSCIENTIFIC	Accolade MRI Pacemakers, Essentio MRI, Proponent MRI, Accolade MRI	2017-08-30
PMA P150012S031 BOSTONSCIENTIFIC	INGEVITY MRI models: 7731, 7732, 7735, 7736, 7740, 7741, 7742	2017-07-27
PMA P150012S030 BOSTONSCIENTIFIC	Ingevity Lead	2017-05-23
PMA P150012S029 BOSTONSCIENTIFIC	Ingevity Lead Manufacturing Changes	2017-05-19
PMA P150012S028 BOSTONSCIENTIFIC	Essentio, Proponent, Accolade MRI.	2017-05-01
PMA P150012S027 BOSTONSCIENTIFIC	INGEVITY Lead	2017-04-19
PMA P150012S021 BOSTONSCIENTIFIC	ESSENTIO, PROPONENT, ACCOLADE, INGEVITY MRI'S & SLIT SUTURE SLEEVE ACCESSORY (FOR INGEVITY MRI LEADS)	2017-04-11
PMA P150012S026 BOSTONSCIENTIFIC	ESSENTIO MRI Models: L110, L111, L131; PROPONENT MRI Models: L210, L211, L231; ACCOLADE MRI Models: L310, L311, L331	2017-03-29
PMA P150012S025 BOSTONSCIENTIFIC	INGEVITY LEADS	2017-01-18
PMA P150012S024 BOSTONSCIENTIFIC	Accolade MRI, Proponent MRI, and Essentio MRI	2017-01-11
PMA P150012S023 BOSTONSCIENTIFIC	INGEVITY NON-MRI LEAD & INGEVITY MRI LEAD	2017-01-10
PMA P150012S022 BOSTONSCIENTIFIC	IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD	2017-01-08
PMA P150012S020 BOSTONSCIENTIFIC	ESSENTIO MRI Models L110, L111, L131;	2016-12-12
PMA P150012S019 BOSTONSCIENTIFIC	INGEVITY	2016-12-07
PMA P150012S018 BOSTONSCIENTIFIC	ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI	2016-11-30
PMA P150012S017 BOSTONSCIENTIFIC	ESSENTIO, PROPONENT, ACCOLADE MRI PACEMAKERS	2016-11-03
PMN K102912 BOSTONSCIENTIFIC	INTERLOCK FIBERED IDC OCCLUSION SYSTEM	2011-03-03
PMN K091131 BOSTONSCIENTIFIC	PELVIC FLOOR REPAIR SYSTEM	2009-05-08
PMN K070002 BOSTONSCIENTIFIC	BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER	2007-08-17
PMN K040027 BOSTONSCIENTIFIC	BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM	2004-03-30

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BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS138 Date Received12/12/2022 Decision Date12/20/2022 Product Codes NVN LWP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS137 Date Received12/09/2022 Decision Date12/15/2022 Product Codes NVN LWP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS136 Date Received12/07/2022 Decision Date12/14/2022 Product Codes LWP NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS135 Date Received11/01/2022 Decision Date11/02/2022 Product Codes LWP NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS133 Date Received10/05/2022 Decision Date10/28/2022 Product Codes LWP NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS130 Date Received09/20/2022 Decision Date09/27/2022 Product Codes LWP NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS127 Date Received07/21/2022 Decision Date07/27/2022 Product Codes NVN LWP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS128 Date Received07/21/2022 Decision Date07/25/2022 Product Codes LWP NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS126 Date Received06/29/2022 Decision Date07/13/2022 Product Codes LWP NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS124 Date Received03/28/2022 Decision Date03/29/2022 Product Codes LWP NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
BOSTONSCIENTIFIC4100 Hamline Avenue Northst Paul, MN 55112 PMA NumberP150012 Supplement NumberS123 Date Received02/23/2022 Decision Date03/08/2022 Product Codes LWP NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

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