PMA
P940024: GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.
FDA PMA · Implantable cardioverter defibrillator (non-CRT) · Telectronics Pacing Systems, Inc.
Key facts
| PMA number | P940024 |
|---|---|
| Trade name | GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB. |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Telectronics Pacing Systems, Inc. |
| Product code | LWS |
| Approval date | Jul 3, 1997 |
| Docket number | 97M-0500 |
| Notice date | Dec 18, 1997 |
At a glance
- None Supplements
- Jul 3, 1997 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: