Singapore HSA registration DE0505294
Medtronic Patient Assistant Model PA97000
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0505294
- Registration Date
- December 31, 2020
- Change Notification Approval Date
- February 15, 2024
- Retention Due Date
- December 30, 2025
Product description
The Patient Assistant is intended for initiating the recording of cardiac event data in the device memory of compatible Medtronic cardiac implantable electronic devices. The Patient Assistant is intended for unsupervised use outside of a hospital or clinic by patients who have received a compatible Medtronic cardiac implantable electronic device.
Product Owner
- Name
- Medtronic Inc.
- Short Name
- Medtronic Inc.
- Address
- 710 Medtronic Parkway N.E., Minneapolis MN 55432, USA, 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)
- Patient Assistant
- Model Identifier(s)
- PA97000
About this record
Access comprehensive regulatory information for Medtronic Patient Assistant Model PA97000 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505294 and owned by Medtronic Inc.. The device was registered on December 31, 2020.
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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