Pure Global

Medtronic Patient Assistant Model PA97000 - HSA Registration DE0505294

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS C
DE0505294
Medtronic Patient Assistant Model PA97000
HSA Registration Number: DE0505294
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

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 Owner
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