PMA
P160012: LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger
FDA PMA · Automated external defibrillators (non-wearable) · Physio-Control, Inc.
Key facts
| PMA number | P160012 |
|---|---|
| Trade name | LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger |
| Generic name | Automated external defibrillators (non-wearable) |
| Applicant | Physio-Control, Inc. |
| Owner/operator | STRYKER CORP. |
| Product code | MKJ |
| Approval date | Dec 21, 2017 |
| Docket number | 17M-6983 |
| Notice date | Mar 20, 2018 |
| Establishment registration | 3015876 |
| FEI number | 3015876 |
At a glance
- 1–9 Supplements
- Apr 18, 2023 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- No Withdrawn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: