CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066
Device Facts
| Record ID | K882427 |
|---|---|
| Device Name | CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066 |
| Applicant | Ela Medical, Inc. |
| Product Code | DXY · Cardiovascular |
| Decision Date | Sep 23, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3610 |
| Device Class | Class 3 |
Regulatory Classification
Identification
An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device may include triggered, inhibited, and asynchronous modes and is implanted in the human body.
