Implantable Pulse Generator, Pacemaker (Non-Crt)
Basic Information
- Device Name
- Implantable Pulse Generator, Pacemaker (Non-Crt)
- Trade Name
- BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS)
- PMA Number
- P010012
- Supplement Number
- S230
- Device Class
- FDA Class 3
- Product Code
- LWP
- Generic Name
- Implantable pulse generator, pacemaker (non-CRT)
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 16, 2010
- Date Received
- December 11, 2009
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- Y
- Docket Number
- 11M-0034
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA class 3 | Unknown |