Approval for the guardian(tm) atp ii model 4211 implantable cardioverter/defibrillator system. The guardian(tm) atp ii model 4211 implantable cardioverter defibrillator hereafter referred to as the 4211 implantable cardioverter defibrillator system consists of the following: the guardian(tm) atp ii model 4211 implantable cardioverter defbrillator; implantable defibrillator patch lead model 040-105, 040-106, 040-107, 040-128, 040-129 and 040-130; model 4510 implant support device; generic 4211 personality modeule; and system accessories (adapter models 040-051, 040-052, 040-047, 040-055, 033-330, and 033-320, model 042-018 patient interface module, model 040-021, stylet kit and cable models 042-010, 042-011, 042-015, 042-238 and 042-017). The 4211 system is indicated for use in patients who are at high risk of sudden death due to ventricular fibrillation and/or ventricular tachyrhythmias and who have experienced one of the following situation: survival of at least one episode of cardiac arrest (manifested by a loss of consciousness) due to ventricular tachyrhythmia or recurrent, poorly tolerated sustained ventricular tachycardia (vt). Note:the clinical outcome for hemodynamically stable, sustained-vt patients is not fully known. Safety and effectiveness studies have not been conducted.
| Device | GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB. |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | TELECTRONICS PACING SYSTEMS, INC. |
| Date Received | 1994-07-08 |
| Decision Date | 1997-07-03 |
| Notice Date | 1997-12-18 |
| PMA | P940024 |
| Supplement | S |
| Product Code | LWS |
| Docket Number | 97M-0500 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TELECTRONICS PACING SYSTEMS, INC. 7400 South Tucson Way englewood, CO 80112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P940024 | Original Filing |