Data / Medical devices / Singapore / Medtronic Singapore Operations Pte Ltd
Medtronic Singapore Operations Pte Ltd: FDA-registered device maker in Singapore Central Singapore, Singapore, 7 510(k) clearances and 4 PMA approvals
Medtronic Singapore Operations Pte Ltd is registered with the FDA (registration 3008973940) in Singapore Central Singapore, Singapore. It lists 10 device types. The FDA files 7 510(k) clearances and 4 PMA approvals under its listings, the newest dated March 28, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008973940
- Address
- 49 Changi South Avenue 2 Nasaco Tech Centre, Singapore Central Singapore, Singapore, 486056
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- January 24, 2007
- Registered through
- 2027
- Brand names listed
- Adapta, Adapta L, Adapta S, Adhesive, Advisa DR, Advisa DR MRI SureScan, Advisa SR MRI SureScan, Attesta DR MRI and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Detector And Alarm, Arrhythmia | DSI | 2 | Manufacturer | accessdata.fda.gov |
| Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | NVN | 3 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | 3 | Manufacturer | accessdata.fda.gov |
| Implantable Pacemaker Pulse-Generator | DXY | 3 | Manufacturer | accessdata.fda.gov |
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | 3 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Permanent Defibrillator Electrodes | NVY | 3 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Permanent Pacemaker Electrode | DTB | 3 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pulse Generator, Permanent, Implantable | NVZ | 3 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | MXD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 28, 2024 | K240693 | LINQ II Insertable Cardiac Monitor (ICM) | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 31, 2023 | K233320 | LINQ II Insertable Cardiac Monitor (LNQ22) | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| August 25, 2022 | K221962 | LINQ II Insertable Cardiac Monitor | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 22, 2021 | K212008 | Reveal LINQ Insertable Cardiac Monitor | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 28, 2021 | K211304 | LINQ II Insertable Cardiac Monitor | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 3, 2020 | K200795 | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 23, 2017 | K162855 | Reveal LINQ | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 8, 2011 | P090013 | REVO MRI SURESCAN IPG AND PACING SYSTEM | LWP | 325 | June 5, 2025 | accessdata.fda.gov |
| January 29, 1999 | P980035 | MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE | NVZ | 822 | October 23, 2026 | accessdata.fda.gov |
| March 29, 1996 | P930039 | MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568 | NVN | 267 | June 24, 2026 | accessdata.fda.gov |
| July 29, 1986 | P830061 | STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING | NVN | 225 | June 24, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- All makers of Implantable Pulse Generator, Pacemaker (Non-Crt)
- All makers of Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
- All makers of Pulse Generator, Permanent, Implantable
- All makers of Implantable Cardioverter Defibrillator (Non-Crt)
- All makers of Implantable Pacemaker Pulse-Generator
Updated June 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.