Medtronic Heart Valves Division

FDA Filings

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

FDA Registration(s)
Registration Number2025587
FEI Number2025587
NameMedtronic Heart Valves Division
Owner & OperatorMEDTRONIC INC.
Contact Address710 Medtronic Pkwy.
Minneapolis MN 55432 US
Official Correspondent
  • CHRISTINE - BOES
  • x-763-5260396-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1851 EAST DEERE AVE.
Santa Ana, CA 92705 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Medtronic Heart Valves Division [MEDTRONIC INC.]
Streamline Temporary Pacing Wire2019-10-04
Medtronic Heart Valves Division [MEDTRONIC INC.]
Streamline Temporary Pacing Leads2019-10-04
Medtronic Heart Valves Division [MEDTRONIC INC.]
Tri-Ad Adams Annuloplasty Ring2018-07-18
Medtronic Heart Valves Division [MEDTRONIC INC.]
Confida Brecker Curve Guidewire2018-05-04
Medtronic Heart Valves Division [MEDTRONIC INC.]
Streamline Temporary Pacing Leads2017-11-01
Medtronic Heart Valves Division [MEDTRONIC INC.]
Avalus? bioprosthesis2017-08-04
Medtronic Heart Valves Division [MEDTRONIC INC.]
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead2016-09-20
Medtronic Heart Valves Division [MEDTRONIC INC.]
Confida Brecker Curve Guidewire2015-08-07
Medtronic Heart Valves Division [MEDTRONIC INC.]
Conduit, Valved, Pulmonic - Contegra2015-07-07
Medtronic Heart Valves Division [MEDTRONIC INC.]
Mosaic2015-07-07
Medtronic Heart Valves Division [MEDTRONIC INC.]
Mosaic ULTRA2015-07-07
Medtronic Heart Valves Division [MEDTRONIC INC.]
Pulmonary Valve2015-01-29
Medtronic Heart Valves Division [MEDTRONIC INC.]
Ensemble2015-01-29
Medtronic Heart Valves Division [MEDTRONIC INC.]
Streamline Temporary Pacing Leads2014-06-10
Medtronic Heart Valves Division [MEDTRONIC INC.]
Medtronic CoreValve System2014-01-17
Medtronic Heart Valves Division [MEDTRONIC INC.]
CoreValve Evolut R System2014-01-17
Medtronic Heart Valves Division [MEDTRONIC INC.]
CoreValve Evolut PRO+ System2014-01-17
Medtronic Heart Valves Division [MEDTRONIC INC.]
CoreValve Evolut PRO System2014-01-17
Medtronic Heart Valves Division [MEDTRONIC INC.]
Confida Brecker Curve Guidewire2013-12-24
Medtronic Heart Valves Division [MEDTRONIC INC.]
Posterior Annuloplasty Band2012-11-26
Medtronic Heart Valves Division [MEDTRONIC INC.]
Medtronic CoreValve System2012-09-17
Medtronic Heart Valves Division [MEDTRONIC INC.]
Ring, Annuloplasty - Contour 3D Ring2012-04-12
Medtronic Heart Valves Division [MEDTRONIC INC.]
ABLATION PEN 4920501 W/PACING2011-11-29
Medtronic Heart Valves Division [MEDTRONIC INC.]
ABLATION PEN 4920501 W/PACING2011-11-29
Medtronic Heart Valves Division [MEDTRONIC INC.]
Tri-Ad Adams Annuloplasty Ring2011-06-17
Medtronic Heart Valves Division [MEDTRONIC INC.]
Simulus Adjustable Annuloplasty Band2011-06-17
Medtronic Heart Valves Division [MEDTRONIC INC.]
Simulus Semi-Rigid Annuloplasty Band2011-06-17
Medtronic Heart Valves Division [MEDTRONIC INC.]
Simulus Semi-Rigid Annuloplasty Ring2011-06-17
Medtronic Heart Valves Division [MEDTRONIC INC.]
Simulus Adjustable Annuloplasty Ring2011-06-17
Medtronic Heart Valves Division [MEDTRONIC INC.]
Simulus Flexible Annuloplasty Band2011-06-17
Medtronic Heart Valves Division [MEDTRONIC INC.]
Simulus Flexible Annuloplasty Ring2011-06-17
Medtronic Heart Valves Division [MEDTRONIC INC.]
heart-valve, non-allograft tissue2010-09-07
Medtronic Heart Valves Division [MEDTRONIC INC.]
melody transcatheter pulm valve2010-02-01
Medtronic Heart Valves Division [MEDTRONIC INC.]
ensemble transcatheter delivery sys2010-02-01
Medtronic Heart Valves Division [MEDTRONIC INC.]
Hancock Bioprosthesis2009-04-01
Medtronic Heart Valves Division [MEDTRONIC INC.]
Profile 3D Annuloplasty Ring2008-06-18
Medtronic Heart Valves Division [MEDTRONIC INC.]
Unipolar Temporary Myocardial2008-01-09
Medtronic Heart Valves Division [MEDTRONIC INC.]
Streamline Convenience 64942008-01-09
Medtronic Heart Valves Division [MEDTRONIC INC.]
Pacing Wire2008-01-09
Medtronic Heart Valves Division [MEDTRONIC INC.]
Unipolar Temporary Atrial Pacing2008-01-09
Medtronic Heart Valves Division [MEDTRONIC INC.]
Streamline Atrial 64922008-01-09
Medtronic Heart Valves Division [MEDTRONIC INC.]
Pacing Lead2008-01-09
Medtronic Heart Valves Division [MEDTRONIC INC.]
CG Future Ring2007-12-28
Medtronic Heart Valves Division [MEDTRONIC INC.]
CG Future Band2007-12-28
Medtronic Heart Valves Division [MEDTRONIC INC.]
Duran Ancore Ring2007-12-28
Medtronic Heart Valves Division [MEDTRONIC INC.]
Duran Ancore Band2007-12-28
Medtronic Heart Valves Division [MEDTRONIC INC.]
Mosaic2007-12-27
Medtronic Heart Valves Division [MEDTRONIC INC.]
Mosaic ULTRA2007-12-27
Medtronic Heart Valves Division [MEDTRONIC INC.]
Mosaic2007-12-27
Medtronic Heart Valves Division [MEDTRONIC INC.]
Mosaic ULTRA2007-12-27
Medtronic Heart Valves Division [MEDTRONIC INC.]
Hancock II2007-12-27
Medtronic Heart Valves Division [MEDTRONIC INC.]
Hancock II Ultra2007-12-27
Medtronic Heart Valves Division [MEDTRONIC INC.]
Freestyle2007-12-27
Medtronic Heart Valves Division [MEDTRONIC INC.]
Hancock Modified Orifice2007-12-27
Medtronic Heart Valves Division [MEDTRONIC INC.]
Hancock MO2007-12-27
Medtronic Heart Valves Division [MEDTRONIC INC.]
Hancock M.O.2007-12-27
Medtronic Heart Valves Division [MEDTRONIC INC.]
Simplici-T2007-12-27
Medtronic Heart Valves Division [MEDTRONIC INC.]
Unipolar Temporary Myocardial2007-12-27
Medtronic Heart Valves Division [MEDTRONIC INC.]
Unipolar Pediatric Temporary Pacing2007-12-27
Medtronic Heart Valves Division [MEDTRONIC INC.]
Streamline Pediatric 64912007-12-27
Medtronic Heart Valves Division [MEDTRONIC INC.]
Pacing Lead2007-12-27
Medtronic Heart Valves Division [MEDTRONIC INC.]
Model 64912007-12-27
Medtronic Heart Valves Division [MEDTRONIC INC.]
Contegra2007-12-27
Medtronic Heart Valves Division [MEDTRONIC INC.]
Temporary Pacing Lead2004-06-08
Medtronic Heart Valves Division [MEDTRONIC INC.]
Streamline2004-06-08
Medtronic Heart Valves Division [MEDTRONIC INC.]
Unipolar Temporary Myocardial2004-06-08
Medtronic Heart Valves Division [MEDTRONIC INC.]
Streamline Premium 65002004-06-08
Medtronic Heart Valves Division [MEDTRONIC INC.]
Pacing Lead2004-06-08
Medtronic Heart Valves Division [MEDTRONIC INC.]
Model 65002004-06-08
Medtronic Heart Valves Division [MEDTRONIC INC.]
pinch on tool1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
Universal Mounting Rail1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
Universal II Slitter1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
Surge Cardiovascular - Coronary Artery Retraction Clips1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
SUTURE BELT1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
STERILIZATION TRAY TOOL1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
SMALL BLADE SET TOOL1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
Rotation Tool Kit1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
RETRACTOR RACK TOOL1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
Mounting Rail1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
MITRAL COLLAR AND TIE1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
MEDIUM BLADE SET TOOL1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
Lead Accessory Kit1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
LARGE BLADE SET TOOL1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
Implant Tool Kit1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
INTERCOSTAL RETRACTOR SYSTEM1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
EXTRA LG BLADE SET TOOL1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
Adjustable Slitter1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
Actuators1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
Accessory Port ATS Medical Thoracic Port System1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
ATRIAL LIFT SYSTEM1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
AORTIC CUFF1992-12-02
Medtronic Heart Valves Division [MEDTRONIC INC.]
TriAd sizers1992-07-30
Medtronic Heart Valves Division [MEDTRONIC INC.]
Simulus Sizers1992-07-30
Medtronic Heart Valves Division [MEDTRONIC INC.]
Profile 3D Ring Sizers1992-07-30
Medtronic Heart Valves Division [MEDTRONIC INC.]
Open Pivot sizers1992-07-30
Medtronic Heart Valves Division [MEDTRONIC INC.]
Mosaic Ultra Supra-X Aortic Sizers1992-07-30
Medtronic Heart Valves Division [MEDTRONIC INC.]
Mosaic Aortic and Mitral Obturators1992-07-30
Medtronic Heart Valves Division [MEDTRONIC INC.]
Hancock II ULTRA Supra-X Aortic Sizers1992-07-30
Medtronic Heart Valves Division [MEDTRONIC INC.]
Hancock II Aortic and Mitral Obturators1992-07-30
Medtronic Heart Valves Division [MEDTRONIC INC.]
Freestyle Obturators1992-07-30
Medtronic Heart Valves Division [MEDTRONIC INC.]
Duran Ancore Sizers1992-07-30
Medtronic Heart Valves Division [MEDTRONIC INC.]
Contour 3D sizers1992-07-30
Medtronic Heart Valves Division [MEDTRONIC INC.]
CG Future Sizers1992-07-30
Medtronic Heart Valves Division [MEDTRONIC INC.]
Avalus? Sizers1992-07-30

Related Finance Registrations

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.