SureTune™ 4 B36104C

by Medtronic, Inc. 2 variants

SureTune™ 4 B36104C is a Class II device made by Medtronic, Inc., granted FDA De Novo DEN210003 on 23 Aug 2021 and listed in FDA GUDID since 8 Jun 2025 (UDI-DI 00763000990435), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

De Novo DEN210003

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00763000990435 UDI-DI	Date8 Jun 2025Listed	StatusListed GUDID: in commercial distribution
United States	FDA De NovoDENG from GUDID De Novo granted · Direct	NumberDEN210003	Date23 Aug 2021Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00763000990435
FDA De Novo database De Novo number DEN210003

Across registries

2 registries list this device

FDA De Novo DEN210003 decided 23 Aug 2021 Active
FDA GUDID UDI-DI 00763000990435 listed 8 Jun 2025 Listed

Timeline

2 dated events

23 Aug 2021 Granted FDA De Novo DEN210003
8 Jun 2025 Listed FDA GUDID 00763000990435

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA De Novo Active

Specification

GUDID

Trade name: SureTune™ 4
Generic name: Implantable electrical stimulation device management software
Model / reference: B36104C

Primary DI / UDI-DI: 00763000990435
De Novo Number: DEN210003
FDA product code: QQC
GMDN term: Implantable electrical stimulation device management software

Device class: Class II
Regulation number: 882.5855
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Lot / batch number

Other properties (13, all answered No)