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Advisa SR MRI™ SureScan™

FDA UDI

Class III (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
Advisa SR MRI™ SureScan™ FDA UDI
Advisa SR MRI™ SureScan® FDA UDI
Generic Name
Single-chamber implantable pacemaker, rate-responsive FDA UDI
Device Name
IPG A3SR01 ADVISA SR MRI US MKT FDA UDI
IPG A3SR01 ADVISA SR MRI IS1 US FDA UDI
Model / Reference
A3SR01 FDA UDI
Description
IPG A3SR01 ADVISA SR MRI US MKT FDA UDI
IPG A3SR01 ADVISA SR MRI IS1 US FDA UDI

Identifiers

Primary DI / UDI-DI
00643169402669 FDA UDI
00763000059620 FDA UDI
PMA Number
P980035 FDA UDI
FDA Product Code
NVZ FDA UDI
LWP FDA UDI
GMDN Term
Single-chamber implantable pacemaker, rate-responsive FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Single-chamber implantable pacemaker, rate-responsive

Advisa SR MRI™ SureScan™ by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Single-chamber implantable pacemaker, rate-responsive.

Cleared under the same submission

P980035 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medtronic, Inc.

Sources (2)

  • FDA UDI 96b7dc00-c36f-4e9f-a0a0-b662a81a2ce3 36 fields · synced May 31, 2026
  • FDA UDI 0e0356e3-49bd-4e6a-8825-52b122677b3d 36 fields · synced May 27, 2026