PMA P980035S549

Device: Advisa MRI DR SureScan, Advisa MRI SR SureScan, Implantable Pulse Generators (IPGs), Attesta DR MRI SureScan (ATDR01), A
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S549
Product code: NVZ
Decision date: 2018-06-28
Classification: Pulse Generator, Permanent, Implantable
Generic name: Pulse generator, permanent, implantable
Approval order statement: Approval for an update to the indications for use to include pacing at the bundle of His. The device, as modified, will be marketed under the trade name SelectSecure MRI SureScan Lead Model 3830 and is indicated for: The Model 3830 lead is intended for pacing and sensing in the atrium or right ventricle. It is also intended for pacing and sensing at the bundle of His as an alternative to right ventricular pacing in a single or dual chamber pacing system.

Current openFDA PMA Record#

Device: Advisa MRI DR SureScan, Advisa MRI SR SureScan, Implantable Pulse Generators (IPGs), Attesta DR MRI SureScan (ATDR01), A
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S549
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2018-06-28
Decision code: APPR
Date received: 2018-04-13
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for an update to the indications for use to include pacing at the bundle of His. The device, as modified, will be marketed under the trade name SelectSecure MRI SureScan Lead Model 3830 and is indicated for: The Model 3830 lead is intended for pacing and sensing in the atrium or right ventricle. It is also intended for pacing and sensing at the bundle of His as an alternative to right ventricular pacing in a single or dual chamber pacing system.