COGNIS CRT-D

FDA premarket approval P010012/S165 · decided 2008-05-08

Approval details

PMA number

P010012

Supplement

S165

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

COGNIS CRT-D

Generic name

Implantable pulse generator, pacemaker (non-CRT)

Applicant

Boston Scientific Corp

Date received

2007-12-07

Decision date

2008-05-08

Days to decision

153 days

Decision code

APPR

Product code

LWP

Advisory committee

Cardiovascular

Expedited review

No

Location

St Paul, MN

Statement

APPROVAL FOR THE TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODELS E102 AND E110, THE COGNIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS N118 AND N119, APPLICATION SOFTWARE MODEL 2868, REV. 1.01 AND THE MODEL 6628 TORQUE WRENCH. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODELS E102 AND E110, THE COGNIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS N118 AND N119, APPLICATION SOFTWARE MODEL

510(k) clearances by this applicant