VITUOSO DR, VIRTUOSO VR, VIRTUOSO II DR, VIRTUOSO II VR, SECURA DR, SECURA VR, PROTECTA XT DR, PROTECTA XT VR

FDA premarket approval P980016/S389 · decided 2013-02-05

Approval details

PMA number

P980016

Supplement

S389

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

VITUOSO DR, VIRTUOSO VR, VIRTUOSO II DR, VIRTUOSO II VR, SECURA DR, SECURA VR, PROTECTA XT DR, PROTECTA XT VR

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

Medtronic Cardiac Rhythm Disease Management

Date received

2012-11-07

Decision date

2013-02-05

Days to decision

90 days

Decision code

APPR

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR CLARIFICATIONS TO THE INDICATIONS FOR USE STATEMENTS RELATED TO THE OPTIVOL FEATURE AND OTHER MODIFICATIONS TO THE DEVICE LABELING. THE DEVICES ARE INDICATED AS FOLLOWS: DUAL CHAMBER ICDSTHE <DEVICE NAME> DR SYSTEM IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. IN ADDITION, THE DEVICE IS INDICATED FOR USE IN THE ABOVE PATIENTS WITH ATRIALTACHYARRHYTHMIAS, OR THOSE PATIENTS