CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER

FDA premarket approval P950029/S001 · decided 1998-12-22

Approval details

PMA number

P950029

Supplement

S001

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER

Generic name

implantable pacemaker Pulse-generator

Applicant

MicroPort CRM USA, Inc.

Date received

1998-08-04

Decision date

1998-12-22

Days to decision

140 days

Decision code

APPR

Product code

DXY

Advisory committee

Cardiovascular

Expedited review

No

Location

Arlington, TN

Statement

Approval for functional changes to reduce size and update algorithms and features in previously approved Chorus RM Model 7034 and Opus RM Model 4534. The device, as modified, will be marketed under the trade name Brio and is indicated for: The generally accepted patient conditions warranting chronic cardiac pacing which include: 1) Symptomatic paroxysmal or permanent second or third-degree AV block; 2) Symptomatic bilateral bundle branch block; 3) Symptomatic paroxysmal or transient sinus node d