Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS)
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: Boston Scientific Corp.; 4100 HAMLINE AVE NORTH; ST. PAUL, MN 55112
• PMA Number: P010012
• Supplement Number: S230
• Date Received: 12/11/2009
• Decision Date: 09/16/2010
• Product Code: LWP
• Docket Number: 11M-0034
• Notice Date: 01/25/2011
• Advisory Committee: Cardiovascular
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: Yes
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order 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 FOLLOWING CLASSIFICATIONS:1) MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III-IV) WITH EF <= 35% AND QRS DURATION>= 120 MS; OR2) LEFT BUNDLE BRANCH BLOCK (LBBB) WITH QRS >= 130 MS, EF <= 30%, AND MILD (NYHACLASS II) ISCHEMIC OR NONISCHEMIC HEART FAILURE OR ASYMPTOMATIC (NYHA CLASS I)ISCHEMIC HEART FAILURE.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling