PMA supplement
P160029 S026: HeartStart Home Defibrillator, HeartStart OnSite Defibrillator, HeartStart HS1 SMART Pads, Adult (M5071A), HeartStart HS
FDA PMA supplement · Real-Time Process · Philips Medical Systems, Inc.
Key facts
| Original PMA | P160029 |
|---|---|
| Supplement number | S026 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | HeartStart Home Defibrillator, HeartStart OnSite Defibrillator, HeartStart HS1 SMART Pads, Adult (M5071A), HeartStart HS |
| Generic name | Over-the-counter automated external defibrillator |
| Applicant | Philips Medical Systems, Inc. |
| Product code | NSA |
| Received date | Sep 13, 2024 |
| Decision date | Dec 12, 2024 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: