EDP 30 EXTERNAL DUAL CHAMBER PACEMAKER

FDA premarket approval P950037/S021 · decided 2001-09-10

Approval details

PMA number

P950037

Supplement

S021

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

EDP 30 EXTERNAL DUAL CHAMBER PACEMAKER

Generic name

permanent pacemaker Electrode

Applicant

Biotronik, Inc.

Date received

2001-07-27

Decision date

2001-09-10

Days to decision

45 days

Decision code

APPR

Product code

DTB

Advisory committee

Cardiovascular

Expedited review

No

Location

Lake Oswego, OR

Statement

APPROVAL FOR THE EXTERNAL DUAL-CHAMBER PACEMAKER MODELS EDP 30. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EDP 30 AND IS INDICATED FOR: 1) TEMPORARY TREATMENT OF ARRHYTHMIAS AND HEART BLOCK; 2) PRE-, INTRA-, AND POSTOPERATIVE TEMPORARY STIMULATION OF PATIENTS UNDERGOING CARDIAC SURGERY; 3) PROPHYLACTIC PACING FOR PREVENTION OF ARRHYTHMIAS, AND 4) EMERGENCY PACING.

510(k) clearances by this applicant