Implantable Cardioverter Defibrillator (Non-Crt)
Basic Information
- Device Name
- Implantable Cardioverter Defibrillator (Non-Crt)
- Trade Name
- RIATA ST MODELS 7000, 7001, 7002, 7010, 7011, & 7012
- PMA Number
- P950022
- Supplement Number
- S027
- Device Class
- FDA Class 3
- Product Code
- LWS
- Generic Name
- Implantable cardioverter defibrillator (non-CRT)
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 7, 2006
- Date Received
- February 10, 2006
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR: 1) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001 AND 7002 ACTIVE-FIXATION DEFIBRILLATION LEADS TO CHANGE THE GEOMETRIC PROFILE OF THE INNER COIL AND ADD WHITE PIGMENT TO THE MEDICAL ADHESIVE USED FOR SHOCK COIL BACKFILL. 2) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001, AND 7002 LEADS TO CREATE AN ACTIVE-FIXATION INTEGRATED BIPOLAR LEAD. THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES RIATA ST MODELS 7010, 7011, AND 7012 AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS. 3) MODIFICATIONS TO THE RIATA ST MODELS 7000, 7001, AND 7002 TO CREATE A PASSIVE FIXATION AND A PASSIVE FIXATION INTEGRATED BIPOLAR LEAD. THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES RIATA ST MODELS 7040, 7041 AND 7042 (PASSIVE FIXATION) AND RIATA ST MODELS 7050, 7051, 7052 (PASSIVE FIXATION INTEGRATED BIPOLAR) AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS.
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 |
|---|---|---|---|
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | FDA class 3 | Unknown |