ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR

FDA premarket approval P980035/S277 · decided 2013-01-15

Approval details

PMA number

P980035

Supplement

S277

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR

Generic name

Pulse generator, permanent, implantable

Applicant

Medtronic, Inc.

Date received

2012-06-29

Decision date

2013-01-15

Days to decision

200 days

Decision code

APPR

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL OF AN MR-CONDITIONAL SYSTEM PERMITTING IMPLANTED PATIENTS TO UNDERGO MRI SCANS PROVIDED SPECIFIED CONDITIONS ARE MET. THE DEVICES, AS MODIFIED, MAKE UP THE ADVISA DR MRI SURESCAN SYSTEM AND WILL BE MARKETED UNDER THE TRADE NAMES ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR WITH SOFTWARE MODEL 9995, CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL 2020A AND DDMA MODEL 2491. THE ADVISA DR MRI SURESCAN SYSTEM IS INDICATED FOR THE FOLLOWING: 1) RATE ADAPTIVE PACING IN PATIENTS WHO

510(k) clearances by this applicant