CONVERT (MODEL V-191) AND CONVERT+ (MODEL V-195) SYSTEMS WITH APPLICATION SOFTWARE MODEL 3307 VERSION 4.9

FDA premarket approval P910023/S081 · decided 2006-05-11

Approval details

PMA number

P910023

Supplement

S081

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

CONVERT (MODEL V-191) AND CONVERT+ (MODEL V-195) SYSTEMS WITH APPLICATION SOFTWARE MODEL 3307 VERSION 4.9

Generic name

Pulse generator, permanent, implantable

Applicant

ABBOTT MEDICAL

Date received

2005-08-08

Decision date

2006-05-11

Days to decision

276 days

Decision code

APPR

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE CONVERT AND CONVERT+ ICD SYSTEMS WITH THE APPLICATION SOFTWARE MODEL 3307 VERSION 4.9. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONVERT AND CONVERT+ ICD SYSTEMS AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING (MODEL V-195 ONLY) AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.

510(k) clearances by this applicant