Medtronic Singapore Operations Pte L T D

FDA Filings

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

FDA Registration(s)

• Registration Number: 3008973940
• FEI Number: 3008973940
• Name: Medtronic Singapore Operations Pte Ltd
• Owner & Operator: MEDTRONIC INC.
• Contact Address: 710 Medtronic Pkwy. ; Minneapolis MN 55432 US
• Official Correspondent:
  • CHRISTINE - BOES
  • x-763-5260396-x
• US Agent:
  • N/A
  • N/A
  • 0
  • N/A
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 49 Changi South Avenue 2 Nasaco Tech Centre; Singapore Not Applicable, 486056 SG
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K162855 | DSI Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Reveal LINQ	2017-02-24
PMN P090013 | NVZ Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Revo MRI SureScan	2011-02-10
PMN P090013 | NVZ Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSureFix MRI SureScan Lead	2011-02-10
PMN P090013 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Revo MRI SureScan	2011-02-10
PMN P090013 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSureFix MRI SureScan Lead	2011-02-10
PMN P090013 | LWP Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Revo MRI SureScan	2011-02-10
PMN P090013 | LWP Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSureFix MRI SureScan Lead	2011-02-10
PMN P830061 | NVY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	stylet kit	2008-03-12
PMN P830061 | NVY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Vitatron Excellence PS+ Lead	2008-03-12
PMN P830061 | NVY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Vitatron Crystalline Lead	2008-03-12
PMN P830061 | NVY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Capsure SP Novus	2008-03-12
PMN P830061 | NVY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSure Unipolar Lead	2008-03-12
PMN P830061 | NVY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSure Sense	2008-03-12
PMN P830061 | NVY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSure Sense MRI SureScan Leads	2008-03-12
PMN P830061 | NVY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Adhesive	2008-03-12
PMN P830061 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	stylet kit	2008-03-12
PMN P830061 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Vitatron Excellence PS+ Lead	2008-03-12
PMN P830061 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Vitatron Crystalline Lead	2008-03-12
PMN P830061 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Capsure SP Novus	2008-03-12
PMN P830061 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSure Unipolar Lead	2008-03-12
PMN P830061 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSure Sense	2008-03-12
PMN P830061 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSure Sense MRI SureScan Leads	2008-03-12
PMN P830061 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Adhesive	2008-03-12
PMN P830061 | DTB Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	stylet kit	2008-03-12
PMN P830061 | DTB Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Vitatron Excellence PS+ Lead	2008-03-12
PMN P830061 | DTB Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Vitatron Crystalline Lead	2008-03-12
PMN P830061 | DTB Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Capsure SP Novus	2008-03-12
PMN P830061 | DTB Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSure Unipolar Lead	2008-03-12
PMN P830061 | DTB Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSure Sense	2008-03-12
PMN P830061 | DTB Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSure Sense MRI SureScan Leads	2008-03-12
PMN P830061 | DTB Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Adhesive	2008-03-12
PMN P930039 | NVY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Vitatron Crystalline Lead	2007-12-06
PMN P930039 | NVY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	SureFix	2007-12-06
PMN P930039 | NVY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSureFix Novus MRI SureScan Leads	2007-12-06
PMN P930039 | NVY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSureFix Novus Leads	2007-12-06
PMN P930039 | NVY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSureFix Lead	2007-12-06
PMN P930039 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Vitatron Crystalline Lead	2007-12-06
PMN P930039 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	SureFix	2007-12-06
PMN P930039 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSureFix Novus MRI SureScan Leads	2007-12-06
PMN P930039 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSureFix Novus Leads	2007-12-06
PMN P930039 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSureFix Lead	2007-12-06
PMN P930039 | DTB Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Vitatron Crystalline Lead	2007-12-06
PMN P930039 | DTB Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	SureFix	2007-12-06
PMN P930039 | DTB Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSureFix Novus MRI SureScan Leads	2007-12-06
PMN P930039 | DTB Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSureFix Novus Leads	2007-12-06
PMN P930039 | DTB Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CapSureFix Lead	2007-12-06
PMN P980035 | NVZ Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Versa	2007-01-24
PMN P980035 | NVZ Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Sensia	2007-01-24
PMN P980035 | NVZ Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Relia IPG	2007-01-24
PMN P980035 | NVZ Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	InCheck Patient Assistant	2007-01-24
PMN P980035 | NVZ Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CareLink SmartSync Azure Astra Application	2007-01-24
PMN P980035 | NVZ Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure XT SR MRI	2007-01-24
PMN P980035 | NVZ Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure XT DR MRI	2007-01-24
PMN P980035 | NVZ Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure S SR MRI	2007-01-24
PMN P980035 | NVZ Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure S DR MRI	2007-01-24
PMN P980035 | NVZ Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Advisa SR MRI SureScan	2007-01-24
PMN P980035 | NVZ Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Advisa DR	2007-01-24
PMN P980035 | NVZ Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Advisa DR MRI SureScan	2007-01-24
PMN P980035 | NVZ Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Adapta	2007-01-24
PMN P980035 | NVZ Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Adapta S	2007-01-24
PMN P980035 | NVZ Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Adapta L	2007-01-24
PMN P980035 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Versa	2007-01-24
PMN P980035 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Sensia	2007-01-24
PMN P980035 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Relia IPG	2007-01-24
PMN P980035 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	InCheck Patient Assistant	2007-01-24
PMN P980035 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CareLink SmartSync Azure Astra Application	2007-01-24
PMN P980035 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure XT SR MRI	2007-01-24
PMN P980035 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure XT DR MRI	2007-01-24
PMN P980035 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure S SR MRI	2007-01-24
PMN P980035 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure S DR MRI	2007-01-24
PMN P980035 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Advisa SR MRI SureScan	2007-01-24
PMN P980035 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Advisa DR	2007-01-24
PMN P980035 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Advisa DR MRI SureScan	2007-01-24
PMN P980035 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Adapta	2007-01-24
PMN P980035 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Adapta S	2007-01-24
PMN P980035 | NVN Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Adapta L	2007-01-24
PMN P980035 | LWS Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Versa	2007-01-24
PMN P980035 | LWS Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Sensia	2007-01-24
PMN P980035 | LWS Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Relia IPG	2007-01-24
PMN P980035 | LWS Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	InCheck Patient Assistant	2007-01-24
PMN P980035 | LWS Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CareLink SmartSync Azure Astra Application	2007-01-24
PMN P980035 | LWS Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure XT SR MRI	2007-01-24
PMN P980035 | LWS Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure XT DR MRI	2007-01-24
PMN P980035 | LWS Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure S SR MRI	2007-01-24
PMN P980035 | LWS Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure S DR MRI	2007-01-24
PMN P980035 | LWS Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Advisa SR MRI SureScan	2007-01-24
PMN P980035 | LWS Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Advisa DR	2007-01-24
PMN P980035 | LWS Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Advisa DR MRI SureScan	2007-01-24
PMN P980035 | LWS Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Adapta	2007-01-24
PMN P980035 | LWS Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Adapta S	2007-01-24
PMN P980035 | LWS Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Adapta L	2007-01-24
PMN P980035 | LWP Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Versa	2007-01-24
PMN P980035 | LWP Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Sensia	2007-01-24
PMN P980035 | LWP Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Relia IPG	2007-01-24
PMN P980035 | LWP Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	InCheck Patient Assistant	2007-01-24
PMN P980035 | LWP Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CareLink SmartSync Azure Astra Application	2007-01-24
PMN P980035 | LWP Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure XT SR MRI	2007-01-24
PMN P980035 | LWP Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure XT DR MRI	2007-01-24
PMN P980035 | LWP Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure S SR MRI	2007-01-24
PMN P980035 | LWP Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure S DR MRI	2007-01-24
PMN P980035 | LWP Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Advisa SR MRI SureScan	2007-01-24
PMN P980035 | LWP Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Advisa DR	2007-01-24
PMN P980035 | LWP Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Advisa DR MRI SureScan	2007-01-24
PMN P980035 | LWP Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Adapta	2007-01-24
PMN P980035 | LWP Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Adapta S	2007-01-24
PMN P980035 | LWP Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Adapta L	2007-01-24
PMN P980035 | DXY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Versa	2007-01-24
PMN P980035 | DXY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Sensia	2007-01-24
PMN P980035 | DXY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Relia IPG	2007-01-24
PMN P980035 | DXY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	InCheck Patient Assistant	2007-01-24
PMN P980035 | DXY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	CareLink SmartSync Azure Astra Application	2007-01-24
PMN P980035 | DXY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure XT SR MRI	2007-01-24
PMN P980035 | DXY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure XT DR MRI	2007-01-24
PMN P980035 | DXY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure S SR MRI	2007-01-24
PMN P980035 | DXY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Azure S DR MRI	2007-01-24
PMN P980035 | DXY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Advisa SR MRI SureScan	2007-01-24
PMN P980035 | DXY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Advisa DR	2007-01-24
PMN P980035 | DXY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Advisa DR MRI SureScan	2007-01-24
PMN P980035 | DXY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Adapta	2007-01-24
PMN P980035 | DXY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Adapta S	2007-01-24
PMN P980035 | DXY Medtronic Singapore Operations Pte Ltd [MEDTRONIC INC.]	Adapta L	2007-01-24