MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER
Device Facts
| Record ID | K884023 |
|---|---|
| Device Name | MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER |
| Applicant | Cardiac Control Systems, Inc. |
| Product Code | DXY · Cardiovascular |
| Decision Date | Oct 17, 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.
