Singapore HSA registration DE0506564
Medtronic SENSIA™ Single Chamber Rate Responsive Pacemaker
Singapore·CLASS D·Medtronic Inc.·Registered January 07, 2022Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0506564
- Registration Date
- January 07, 2022
- Change Notification Approval Date
- April 18, 2024
- Retention Due Date
- January 06, 2026
Product description
Medtronic Sensia implantable pulse generators (IPGs) are indicated for use to improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. These devices are indicated for use in patients who are experiencing exercise intolerance or exercise restrictions related to an arrhythmia. Using rate response modes may restore heart rate variability and improve cardiac output. Sensia SR Series implantable pulse generators are indicated for single use only.
Product Owner
- Name
- Medtronic Inc.
- Short Name
- Medtronic
- Address
- 710 Medtronic Parkway, Minneapolis, MN 55432-5604, UNITED STATES
Registrant
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model information
- Model Name(s)
- Medtronic SENSIA™ Single Chamber Rate Responsive Pacemaker
- Model Identifier(s)
- SESR01
About this record
Access comprehensive regulatory information for Medtronic SENSIA™ Single Chamber Rate Responsive Pacemaker in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506564 and owned by Medtronic Inc.. The device was registered on January 07, 2022.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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