Abbott Medical

FDA Filings

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

Latest Premarket Notifications

Manufacturer	Device Name	Date
K192019 Abbott Medical	Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software Version E.5.1	2019-11-08
K192037 Abbott Medical	Advisor VL Circular Mapping Catheter, Sensor Enabled	2019-09-17
K190581 Abbott Medical	Amplatzer Treviso Intravascular Delivery System	2019-04-05

Latest Premarket Applications

PMA	Manufacturer	Device Name	Date
P150004S032	Abbott Medical	Axium Neurostimulator System	2019-11-19
P010032S155	Abbott Medical	Genesis Neurostimulation System	2019-11-19
P140009S051	Abbott Medical	Brio Neurostimulation System	2019-11-19
P040040S038	Abbott Medical	Amplatzer Muscular VSD Occluder	2019-10-25
P000039S068	Abbott Medical	Amplatzer Septal Occluder and Amplatzer Multi-Fenestrated Septal Occluder	2019-10-25
P020024S058	Abbott Medical	Amplatzer Duct Occluder, Amplatzer Duct Occluder II and Amplatzer Septal Occluder	2019-10-25
P120021S013	Abbott Medical	Amplatzer PFO Occluder	2019-10-25
P010032S154	Abbott Medical	Torque Wrench	2019-09-26
P140009S050	Abbott Medical	Infinity Deep Brain Stimulation (DBS) System	2019-09-05
P120021S012	Abbott Medical	AMPLATZER PFO OCCLUDER	2019-08-22
P000039S067	Abbott Medical	THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM	2019-08-22
P040040S037	Abbott Medical	AMPLATZER MUSCULAR VSD OCCLUDER	2019-08-22
P020024S057	Abbott Medical	AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM	2019-08-22
P150004S030	Abbott Medical	Axium Neurostimulator System	2019-07-31
P010032S153	Abbott Medical	GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS	2019-07-29
P140009S048	Abbott Medical	BRIO NEUROSTIMULATION SYSTEM	2019-07-29
P150004S031	Abbott Medical	Axium Neurostimulator System	2019-07-29
P010032S152	Abbott Medical	GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS	2019-07-17
P010032S150	Abbott Medical	Genesis Neurostimulation System	2019-07-15
P140009S047	Abbott Medical	Brio Neurostimulation System	2019-07-15
P010032S148	Abbott Medical	Proclaim SCS Neurostimulation System FW	2019-05-03
P000039S066	Abbott Medical	Amplatzer Septal Occluder	2019-04-18
P010032S147	Abbott Medical	SCS EPG Header	2019-03-26
P150004S023	Abbott Medical	Axium Neurostimulator System	2019-03-26
P040040S036	Abbott Medical	Amplatzer Muscular VSD Occluder	2019-03-25
P120021S011	Abbott Medical	Amplatzer Patent FOramen Ovale Occluder	2019-03-25
P020024S056	Abbott Medical	Amplatzer Duct Occluder, Amplatzer Duct Occluder II and Amplatzer Piccolo Occluder	2019-03-25
P000039S065	Abbott Medical	Amplatzer Septal Occluder and Amplatzer Cribriform Occluder	2019-03-25
P140009S045	Abbott Medical	Multilead Trial Cable (MLTC)	2019-03-13
P040040S035	Abbott Medical	AMPLATZER Muscular VSD Occluder	2019-03-05

Latest De Novo Filings

De Novo	Manufacturer	Device Name	Date

GUDID Registrations

Device GUDID Device Name	Manufacturer	Date
05050474636347 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636330 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636323 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636316 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636309 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636293 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636286 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636279 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636262 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636255 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636248 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636231 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636224 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636217 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636200 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636194 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636187 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636170 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636163 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636156 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636149 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636132 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636125 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636118 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636101 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636095 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636088 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636071 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636064 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636057 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636040 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636033 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636026 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636019 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26
05050474636002 TECNIS SIMPLICITY	ABBOTT MEDICAL OPTICS INC.	2019-11-26