OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004
Device Facts
| Record ID | K882474 |
|---|---|
| Device Name | OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004 |
| Applicant | Ela Medical, Inc. |
| Product Code | DXY · Cardiovascular |
| Decision Date | Sep 12, 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.
