BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS)

FDA premarket approval P010012/S230 · decided 2010-09-16

Approval details

PMA number

P010012

Supplement

S230

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS)

Generic name

Implantable pulse generator, pacemaker (non-CRT)

Applicant

Boston Scientific Corp

Date received

2009-12-11

Decision date

2010-09-16

Days to decision

279 days

Decision code

APPR

Product code

LWP

Advisory committee

Cardiovascular

Expedited review

Yes

Location

St Paul, MN

Statement

APPROVAL FOR A MODIFICATION TO THE INDICATIONS FOR USE FOR THE COGNIS CRT-D MODELS N118, N119; LIVIANCRT-D MODELS H220, H225, H227 AND H229; AND CONTAK RENEWAL 3 RF HE CRT-D MODELSH210, H215, H217, H219 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) AS FOLLOWS:THESE BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) ARE INDICATED FOR PATIENTS WITH HEART FAILURE WHO RECEIVE STABLE OPTIMAL PHARMACOLOGIC THERAPY (OPT) FOR HEART FAILURE AND WHO MEET ANY ONE OF THE

510(k) clearances by this applicant