PMA
P000009: PHYLAX AV ICD SYSTEM
FDA PMA · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER · Biotronik, Inc.
Key facts
| PMA number | P000009 |
|---|---|
| Trade name | PHYLAX AV ICD SYSTEM |
| Generic name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
| Applicant | Biotronik, Inc. |
| Owner/operator | BIOTRONIK, INC. |
| Product code | MRM |
| Approval date | Sep 29, 2000 |
| Docket number | 01M-0042 |
| Notice date | Jan 23, 2001 |
| Establishment registration | 1028232 |
| FEI number | 1028232 |
At a glance
- 100–999 Supplements
- Oct 9, 2026 Latest supplement decision
- No Withdrawn
- Yes 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: