Advisa MRI DR SureScan, Advisa MRI SR SureScan, Implantable Pulse Generators (IPGs), Attesta DR MRI SureScan (ATDR01), A

FDA premarket approval P980035/S549 · decided 2018-06-28

Approval details

PMA number

P980035

Supplement

S549

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

Advisa MRI DR SureScan, Advisa MRI SR SureScan, Implantable Pulse Generators (IPGs), Attesta DR MRI SureScan (ATDR01), A

Generic name

Pulse generator, permanent, implantable

Applicant

Medtronic, Inc.

Date received

2018-04-13

Decision date

2018-06-28

Days to decision

76 days

Decision code

APPR

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

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.

510(k) clearances by this applicant