PMA
P980023: PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
FDA PMA · Implantable cardioverter defibrillator (non-CRT) · Biotronik, Inc.
Key facts
| PMA number | P980023 |
|---|---|
| Trade name | PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Biotronik, Inc. |
| Owner/operator | BIOTRONIK, INC. |
| Product code | LWS |
| Approval date | Oct 27, 1998 |
| Docket number | 98M-0972 |
| Notice date | Nov 18, 1998 |
| Establishment registration | 1028232 |
| FEI number | 1028232 |
At a glance
- 100–999 Supplements
- Oct 9, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 100–999 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: