MEDTRONIC MODEL 7278 MAXIMO DR ICD AND MODEL 7232 MAXIMO VR ICD SYSTEMS, WITH MODEL 9978 VERSION 1.0 APPLICATION SOFTWA

FDA premarket approval P980016/S037 · decided 2003-10-06

Approval details

PMA number

P980016

Supplement

S037

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC MODEL 7278 MAXIMO DR ICD AND MODEL 7232 MAXIMO VR ICD SYSTEMS, WITH MODEL 9978 VERSION 1.0 APPLICATION SOFTWA

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

Medtronic Cardiac Rhythm Disease Management

Date received

2003-09-08

Decision date

2003-10-06

Days to decision

28 days

Decision code

APPR

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL TO MODIFY THE MARQUIS VR AND DR SYSTEMS TO PROVIDE INCREASED ENERGY OUTPUT (35J). THE DEVICES WILL BE USED WITH THE FOLLOWING APPLICATION SOFTWARE VERSIONS: MODEL 9978 VERSION 1.0 APPLICATION SOFTWARE FOR USE WITH THE MAXIMO DR, AND MODEL 9979 VERSION 1.0 APPLICATION SOFTWARE FOR USE WITH MAXIMO VR. THE APPLICATION SOFTWARE MAY BE INSTALLED ON EITHER 9790C OR 2090 PROGRAMMERS. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MAXIMO DR/VR ICD SYSTEM AND ARE INDICATED AS FO