HSA · registration DE0505353Medtronic LINQ II™ Insertable Cardiac Monitor (ICM)
SingaporeCardiovascularClass DMedtronic Inc.
Official record identity
- Registration number
- DE0505353
- Model name
- Instrument Command Library (ICL); Device Command Library (DCL); LINQ II ICM; LINQ II Insertion Tools
- Model identifier
- 2691; 2692; LNQ22; LNQ22TK
- Registration date
- January 15, 2021
- Source update date
- February 21, 2024
Classification
- Risk class
- Class D
Official value: CLASS D
Published parties
- Product owner
- Medtronic Inc.
- Registrant / registration holder
- MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)
Official description
The LINQ II insertable cardiac monitor is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and other physiological parameters and is indicated in the following cases: • Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias • Patients who experience transient symptoms that may suggest a cardiac arrhythmia
Additional source fields
- Product owner address
- 710 Medtronic Parkway N.E., Minneapolis MN 55432, USA, United States
- Registrant address
- 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.