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

ManufacturerDevice NameDate
Abbott Medical
Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software Version E.5.12019-11-08
Abbott Medical
Advisor VL Circular Mapping Catheter, Sensor Enabled2019-09-17
Abbott Medical
Amplatzer Treviso Intravascular Delivery System2019-04-05

Latest Premarket Applications

PMAManufacturerDevice NameDate
Abbott Medical
Axium Neurostimulator System2019-11-19
Abbott Medical
Genesis Neurostimulation System2019-11-19
Abbott Medical
Brio Neurostimulation System2019-11-19
Abbott Medical
Amplatzer Muscular VSD Occluder2019-10-25
Abbott Medical
Amplatzer Septal Occluder and Amplatzer Multi-Fenestrated Septal Occluder2019-10-25
Abbott Medical
Amplatzer Duct Occluder, Amplatzer Duct Occluder II and Amplatzer Septal Occluder2019-10-25
Abbott Medical
Amplatzer PFO Occluder2019-10-25
Abbott Medical
Torque Wrench2019-09-26
Abbott Medical
Infinity Deep Brain Stimulation (DBS) System2019-09-05
Abbott Medical
AMPLATZER PFO OCCLUDER2019-08-22
Abbott Medical
THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM2019-08-22
Abbott Medical
AMPLATZER MUSCULAR VSD OCCLUDER2019-08-22
Abbott Medical
AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM2019-08-22
Abbott Medical
Axium Neurostimulator System2019-07-31
Abbott Medical
GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS2019-07-29
Abbott Medical
BRIO NEUROSTIMULATION SYSTEM2019-07-29
Abbott Medical
Axium Neurostimulator System2019-07-29
Abbott Medical
GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS2019-07-17
Abbott Medical
Genesis Neurostimulation System2019-07-15
Abbott Medical
Brio Neurostimulation System2019-07-15
Abbott Medical
Proclaim SCS Neurostimulation System FW2019-05-03
Abbott Medical
Amplatzer Septal Occluder2019-04-18
Abbott Medical
SCS EPG Header2019-03-26
Abbott Medical
Axium Neurostimulator System2019-03-26
Abbott Medical
Amplatzer Muscular VSD Occluder2019-03-25
Abbott Medical
Amplatzer Patent FOramen Ovale Occluder2019-03-25
Abbott Medical
Amplatzer Duct Occluder, Amplatzer Duct Occluder II and Amplatzer Piccolo Occluder2019-03-25
Abbott Medical
Amplatzer Septal Occluder and Amplatzer Cribriform Occluder2019-03-25
Abbott Medical
Multilead Trial Cable (MLTC)2019-03-13
Abbott Medical
AMPLATZER Muscular VSD Occluder2019-03-05

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26
TECNIS SIMPLICITY
ABBOTT MEDICAL OPTICS INC.2019-11-26

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