PMA
P160026: LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE
FDA PMA · Automated external defibrillators (non-wearable) · Physio-Control, Inc.
Key facts
| PMA number | P160026 |
|---|---|
| Trade name | LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE |
| Generic name | Automated external defibrillators (non-wearable) |
| Applicant | Physio-Control, Inc. |
| Owner/operator | STRYKER CORP. |
| Product code | MKJ |
| Approval date | Jul 2, 2018 |
| Docket number | 18M-2883 |
| Notice date | Aug 22, 2018 |
| Establishment registration | 3015876 |
| FEI number | 3015876 |
At a glance
- 10–99 Supplements
- Sep 24, 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- No Withdrawn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: