GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.
Device Facts
| Record ID | P940024 |
|---|---|
| Device Name | GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB. |
| Applicant | Telectronics Pacing Systems, Inc. |
| Product Code | LWS · Cardiovascular |
| Decision Date | Jul 3, 1997 |
| Decision | APPR |
| Device Class | Class 3 |
Regulatory Classification
Identification
These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.
