Medtronic

FDA Filings

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

Medtronic holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3013060098
FEI Number3013060098
NameAndrea Mitchell
Owner & OperatorMedtronic
Contact Address16720 Trans-Canada, Suite 200
Kirkland CA-QC Quebec H9H 4M7 CA
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address15 Hampshire Street
Mansfield, MA 02048 US
Establishment TypeExport Device to the United States But Perform No Other Operation on Device



Registration Number3011144059
FEI Number3011144059
NameJes Duval
Owner & OperatorMedtronic
Contact Address15 Hampshire Street
Mansfield MA 02048 US
US Agent
  • Jes Duval
  • 508 4521904
  • jessica.duval@medtronic.com
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address15 Hampshire Street
Mansfield, MA 02048 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



FDA Owner/Operator Registration


























































FDA Filings

Device
Company
DeviceDate
Medtronic
HeartWare Ventricular Assist System2020-07-20
Medtronic
HeartWare Ventricular Assist System2020-07-15
Medtronic
HeartWare Ventricular Assist System2020-06-22
Medtronic
Cardioblate Gemini-s Surgical Ablation Device2020-06-03
Medtronic
HeartWare Ventricular Assist System2020-06-03
Medtronic
HeartWare Ventricular Assist System2020-05-06
Medtronic
VS3-IR2019-11-25
Medtronic
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead2019-08-08
Medtronic
Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter2019-07-30
Medtronic
Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter2019-07-30
Medtronic
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device2019-05-30
Andrea Mitchell [Medtronic]
Valleylab2019-04-08
Andrea Mitchell [Medtronic]
REM Polyhesive Neonatal Patient Return Electrode2019-04-08
Medtronic
VS3-IR2019-03-04
Medtronic
Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device2018-12-19
Medtronic
Tri-Ad 2.0 Adams Tricuspid Band2018-05-29
Medtronic
KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set2017-10-23
Jes Duval [Medtronic]
Chameleon PTA Balloon Catheter2017-08-07
Jes Duval [Medtronic]
Chameleon PTA Balloon Catheter2017-08-07

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