MODEL 6996 SQ LEAD SYSTEM AND 6996T TUNNELING TOOL

FDA premarket approval P920015/S021 · decided 2001-06-11

Approval details

PMA number

P920015

Supplement

S021

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MODEL 6996 SQ LEAD SYSTEM AND 6996T TUNNELING TOOL

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

Medtronic, Inc.

Date received

2001-02-05

Decision date

2001-06-11

Days to decision

126 days

Decision code

APPR

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR THE MODEL 6996 SQ LEAD SYSTEM AND THE 6996T TUNNELING TOOL. THE MODEL 6996 SQ LEAD SYSTEM IS FOR SINGLE, LONG-TERM SUBCUTANEOUS USE AND IS INTENDED FOR USE IN PATIENTS IN WHICH IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) ARE INDICATED. THE LEAD IS INTENDED FOR USE IF A STANDARD ICD SYSTEM WITH ONE OR TWO TRANSVENOUS LEADS HAS NOT BEEN EFFICACIOUS IN PROVIDING ACCEPTABLE DFT MEASUREMENTS. THE MODEL 6996 SQ LEAD IS INTENDED FOR USE ONLY WITH THE FOLLOWING SYSTEMS: A MEDTRONIC ICD FE

510(k) clearances by this applicant