HSA · registration DE0506563Medtronic Sensia Dual Chamber Pacemakers
- Registration number
- DE0506563
- Model name
- Medtronic SENSIA™ Dual Chamber Pacemaker; Medtronic SENSIA™ Dual Chamber Rate Responsive Pacemaker; Medtronic SENSIA™ Dual Chamber Rate Responsive Pacemaker
- Model identifier
- SED01; SEDR01; SEDRL1
- Registration date
- January 07, 2022
- Source update date
- April 22, 2022
- Risk class
- Class D
- Product owner
- Medtronic Inc.
- Registrant / registration holder
- MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)
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 D/DR Series implantable pulse generators are indicated for single use only.
- Product owner address
- 710 Medtronic Parkway, Minneapolis, MN 55432-5604, United States
- Registrant address
- 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
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.