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 Number: 2025587
• FEI Number: 2025587
• Name: Medtronic Heart Valves Division
• Owner & Operator: MEDTRONIC INC.
• Contact Address: 710 Medtronic Pkwy. ; Minneapolis MN 55432 US
• Official Correspondent:
  • CHRISTINE - BOES
  • x-763-5260396-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1851 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	Device	Date
PMN K190716 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Streamline Temporary Pacing Wire	2019-10-04
PMN K190716 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Streamline Temporary Pacing Leads	2019-10-04
PMN K181132 | KRH Medtronic Heart Valves Division [MEDTRONIC INC.]	Tri-Ad Adams Annuloplasty Ring	2018-07-18
PMN K181001 | DQX Medtronic Heart Valves Division [MEDTRONIC INC.]	Confida Brecker Curve Guidewire	2018-05-04
PMN K171253 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Streamline Temporary Pacing Leads	2017-11-01
PMN P170006 | LWR Medtronic Heart Valves Division [MEDTRONIC INC.]	Avalus? bioprosthesis	2017-08-04
PMN K161249 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Streamline 6495 Bipolar Temporary Myocardial Pacing Lead	2016-09-20
PMN K150465 | DQX Medtronic Heart Valves Division [MEDTRONIC INC.]	Confida Brecker Curve Guidewire	2015-08-07
MWH Medtronic Heart Valves Division [MEDTRONIC INC.]	Conduit, Valved, Pulmonic - Contegra	2015-07-07
DYE Medtronic Heart Valves Division [MEDTRONIC INC.]	Mosaic	2015-07-07
DYE Medtronic Heart Valves Division [MEDTRONIC INC.]	Mosaic ULTRA	2015-07-07
PMN P140017 | NPV Medtronic Heart Valves Division [MEDTRONIC INC.]	Pulmonary Valve	2015-01-29
PMN P140017 | NPV Medtronic Heart Valves Division [MEDTRONIC INC.]	Ensemble	2015-01-29
PMN K140972 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Streamline Temporary Pacing Leads	2014-06-10
PMN P130021 | NPT Medtronic Heart Valves Division [MEDTRONIC INC.]	Medtronic CoreValve System	2014-01-17
PMN P130021 | NPT Medtronic Heart Valves Division [MEDTRONIC INC.]	CoreValve Evolut R System	2014-01-17
PMN P130021 | NPT Medtronic Heart Valves Division [MEDTRONIC INC.]	CoreValve Evolut PRO+ System	2014-01-17
PMN P130021 | NPT Medtronic Heart Valves Division [MEDTRONIC INC.]	CoreValve Evolut PRO System	2014-01-17
PMN K132623 | DQX Medtronic Heart Valves Division [MEDTRONIC INC.]	Confida Brecker Curve Guidewire	2013-12-24
PMN K960356 | KRH Medtronic Heart Valves Division [MEDTRONIC INC.]	Posterior Annuloplasty Band	2012-11-26
NPT Medtronic Heart Valves Division [MEDTRONIC INC.]	Medtronic CoreValve System	2012-09-17
PMN K101212 | KRH Medtronic Heart Valves Division [MEDTRONIC INC.]	Ring, Annuloplasty - Contour 3D Ring	2012-04-12
PMN K090721 | OCL Medtronic Heart Valves Division [MEDTRONIC INC.]	ABLATION PEN 4920501 W/PACING	2011-11-29
PMN K090721 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	ABLATION PEN 4920501 W/PACING	2011-11-29
PMN K093903 | KRH Medtronic Heart Valves Division [MEDTRONIC INC.]	Tri-Ad Adams Annuloplasty Ring	2011-06-17
PMN K090428 | KRH Medtronic Heart Valves Division [MEDTRONIC INC.]	Simulus Adjustable Annuloplasty Band	2011-06-17
PMN K083683 | KRH Medtronic Heart Valves Division [MEDTRONIC INC.]	Simulus Semi-Rigid Annuloplasty Band	2011-06-17
PMN K072655 | KRH Medtronic Heart Valves Division [MEDTRONIC INC.]	Simulus Semi-Rigid Annuloplasty Ring	2011-06-17
PMN K071214 | KRH Medtronic Heart Valves Division [MEDTRONIC INC.]	Simulus Adjustable Annuloplasty Ring	2011-06-17
PMN K052899 | KRH Medtronic Heart Valves Division [MEDTRONIC INC.]	Simulus Flexible Annuloplasty Band	2011-06-17
PMN K052565 | KRH Medtronic Heart Valves Division [MEDTRONIC INC.]	Simulus Flexible Annuloplasty Ring	2011-06-17
PMN P060025 | LWR Medtronic Heart Valves Division [MEDTRONIC INC.]	heart-valve, non-allograft tissue	2010-09-07
PMN H080002 | NPV Medtronic Heart Valves Division [MEDTRONIC INC.]	melody transcatheter pulm valve	2010-02-01
PMN H080002 | NPV Medtronic Heart Valves Division [MEDTRONIC INC.]	ensemble transcatheter delivery sys	2010-02-01
PMN P870078 | DYE Medtronic Heart Valves Division [MEDTRONIC INC.]	Hancock Bioprosthesis	2009-04-01
PMN K073324 | KRH Medtronic Heart Valves Division [MEDTRONIC INC.]	Profile 3D Annuloplasty Ring	2008-06-18
PMN K012459 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Unipolar Temporary Myocardial	2008-01-09
PMN K012459 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Streamline Convenience 6494	2008-01-09
PMN K012459 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Pacing Wire	2008-01-09
PMN K012458 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Unipolar Temporary Atrial Pacing	2008-01-09
PMN K012458 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Streamline Atrial 6492	2008-01-09
PMN K012458 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Pacing Lead	2008-01-09
PMN K061127 | KRH Medtronic Heart Valves Division [MEDTRONIC INC.]	CG Future Ring	2007-12-28
PMN K052860 | KRH Medtronic Heart Valves Division [MEDTRONIC INC.]	CG Future Band	2007-12-28
PMN K032810 | KRH Medtronic Heart Valves Division [MEDTRONIC INC.]	Duran Ancore Ring	2007-12-28
PMN K032810 | KRH Medtronic Heart Valves Division [MEDTRONIC INC.]	Duran Ancore Band	2007-12-28
PMN P990064 | LWR Medtronic Heart Valves Division [MEDTRONIC INC.]	Mosaic	2007-12-27
PMN P990064 | LWR Medtronic Heart Valves Division [MEDTRONIC INC.]	Mosaic ULTRA	2007-12-27
PMN P990064 | DYE Medtronic Heart Valves Division [MEDTRONIC INC.]	Mosaic	2007-12-27
PMN P990064 | DYE Medtronic Heart Valves Division [MEDTRONIC INC.]	Mosaic ULTRA	2007-12-27
PMN P980043 | DYE Medtronic Heart Valves Division [MEDTRONIC INC.]	Hancock II	2007-12-27
PMN P980043 | DYE Medtronic Heart Valves Division [MEDTRONIC INC.]	Hancock II Ultra	2007-12-27
PMN P970031 | LWR Medtronic Heart Valves Division [MEDTRONIC INC.]	Freestyle	2007-12-27
PMN P790007 | LWR Medtronic Heart Valves Division [MEDTRONIC INC.]	Hancock Modified Orifice	2007-12-27
PMN P790007 | LWR Medtronic Heart Valves Division [MEDTRONIC INC.]	Hancock MO	2007-12-27
PMN P790007 | LWR Medtronic Heart Valves Division [MEDTRONIC INC.]	Hancock M.O.	2007-12-27
PMN K052970 | KRH Medtronic Heart Valves Division [MEDTRONIC INC.]	Simplici-T	2007-12-27
PMN K012454 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Unipolar Temporary Myocardial	2007-12-27
PMN K012454 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Unipolar Pediatric Temporary Pacing	2007-12-27
PMN K012454 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Streamline Pediatric 6491	2007-12-27
PMN K012454 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Pacing Lead	2007-12-27
PMN K012454 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Model 6491	2007-12-27
PMN H020003 | MWH Medtronic Heart Valves Division [MEDTRONIC INC.]	Contegra	2007-12-27
PMN K012460 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Temporary Pacing Lead	2004-06-08
PMN K012460 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Streamline	2004-06-08
PMN K012452 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Unipolar Temporary Myocardial	2004-06-08
PMN K012452 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Streamline Premium 6500	2004-06-08
PMN K012452 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Pacing Lead	2004-06-08
PMN K012452 | LDF Medtronic Heart Valves Division [MEDTRONIC INC.]	Model 6500	2004-06-08
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	pinch on tool	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	Universal Mounting Rail	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	Universal II Slitter	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	Surge Cardiovascular - Coronary Artery Retraction Clips	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	SUTURE BELT	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	STERILIZATION TRAY TOOL	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	SMALL BLADE SET TOOL	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	Rotation Tool Kit	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	RETRACTOR RACK TOOL	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	Mounting Rail	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	MITRAL COLLAR AND TIE	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	MEDIUM BLADE SET TOOL	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	Lead Accessory Kit	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	LARGE BLADE SET TOOL	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	Implant Tool Kit	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	INTERCOSTAL RETRACTOR SYSTEM	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	EXTRA LG BLADE SET TOOL	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	Adjustable Slitter	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	Actuators	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	Accessory Port ATS Medical Thoracic Port System	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	ATRIAL LIFT SYSTEM	1992-12-02
DWS Medtronic Heart Valves Division [MEDTRONIC INC.]	AORTIC CUFF	1992-12-02
DTI Medtronic Heart Valves Division [MEDTRONIC INC.]	TriAd sizers	1992-07-30
DTI Medtronic Heart Valves Division [MEDTRONIC INC.]	Simulus Sizers	1992-07-30
DTI Medtronic Heart Valves Division [MEDTRONIC INC.]	Profile 3D Ring Sizers	1992-07-30
DTI Medtronic Heart Valves Division [MEDTRONIC INC.]	Open Pivot sizers	1992-07-30
DTI Medtronic Heart Valves Division [MEDTRONIC INC.]	Mosaic Ultra Supra-X Aortic Sizers	1992-07-30
DTI Medtronic Heart Valves Division [MEDTRONIC INC.]	Mosaic Aortic and Mitral Obturators	1992-07-30
DTI Medtronic Heart Valves Division [MEDTRONIC INC.]	Hancock II ULTRA Supra-X Aortic Sizers	1992-07-30
DTI Medtronic Heart Valves Division [MEDTRONIC INC.]	Hancock II Aortic and Mitral Obturators	1992-07-30
DTI Medtronic Heart Valves Division [MEDTRONIC INC.]	Freestyle Obturators	1992-07-30
DTI Medtronic Heart Valves Division [MEDTRONIC INC.]	Duran Ancore Sizers	1992-07-30
DTI Medtronic Heart Valves Division [MEDTRONIC INC.]	Contour 3D sizers	1992-07-30
DTI Medtronic Heart Valves Division [MEDTRONIC INC.]	CG Future Sizers	1992-07-30
DTI Medtronic Heart Valves Division [MEDTRONIC INC.]	Avalus? Sizers	1992-07-30