PMA
P160029: HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)
FDA PMA · Over-the-counter automated external defibrillator · Philips Medical Systems, Inc.
Key facts
| PMA number | P160029 |
|---|---|
| Trade name | HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) |
| Generic name | Over-the-counter automated external defibrillator |
| Applicant | Philips Medical Systems, Inc. |
| Owner/operator | Philips Medical Systems International BV |
| Product code | NSA |
| Approval date | Jun 6, 2019 |
| Docket number | 19M-2782 |
| Notice date | Jul 2, 2019 |
| Establishment registration | 3018004899 |
| FEI number | 3018004899 |
At a glance
- 10–99 Supplements
- Feb 2, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: