MEDTRONIC MODEL P1501DR ENRHYTHM IMPLANTABLE PULSE GENERATOR, MEDTRONIC MODEL 9987 APPLICATION SOFTWARE AND MEDTRONIC MO

FDA premarket approval P980035/S038 · decided 2005-04-28

Approval details

PMA number

P980035

Supplement

S038

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC MODEL P1501DR ENRHYTHM IMPLANTABLE PULSE GENERATOR, MEDTRONIC MODEL 9987 APPLICATION SOFTWARE AND MEDTRONIC MO

Generic name

implantable pacemaker Pulse-generator

Applicant

Medtronic, Inc.

Date received

2004-04-27

Decision date

2005-04-28

Days to decision

366 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

APPROVAL FOR THE MEDTRONIC MODEL P1501DR ENRHYTHM IMPLANTABLE PULSE GENERATOR, MEDTRONIC MODEL 9987 APPLICATION SOFTWARE AND MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT. THE CEVICE IS INDICATE FOR THE FOLLWOING: 1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN ACTIVITY. 2) ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREE AV BLOCK, SYMPTOMATIC BILAT

510(k) clearances by this applicant