MEDTRONIC ENPULSE IMPLANTABLE PULSE GENERATOR AND MODEL 9991 APPLICATION SOFTWARE

FDA premarket approval P980035/S032 · decided 2004-02-20

Approval details

PMA number

P980035

Supplement

S032

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC ENPULSE IMPLANTABLE PULSE GENERATOR AND MODEL 9991 APPLICATION SOFTWARE

Generic name

implantable pacemaker Pulse-generator

Applicant

Medtronic, Inc.

Date received

2003-08-29

Decision date

2004-02-20

Days to decision

175 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR THE ENPULSE IMPLANTABLE PULSE GENERATOR MODELS E2DR01, E2DR03, E2DR06, E2DR21, E2DR31, E2DR33, E2D01, E2D03, E2VDD01, E2SR01, E2SR03, E2SR06 WITH ATRIAL CAPTURE MANAGEMENT AND MODEL 9991 APPLICATION SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENPULSE IPG AND IS INDICATED AS FOLLOWS: ENPULSE PACEMAKERS ARE INDICATED FOR USE IN PATIENTS WHO ARE EXPERIENCING ACCEPTED CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: 1) SYMPTOMATIC PAROXYSMAL OR PE

510(k) clearances by this applicant