PMA supplement
P160029 S024: HeartStart HS1 Onsite Defibrillator (M5066A), HeartStart HS1 Home Defibrillator (M5068A)
FDA PMA supplement · Normal 180 Day Track No User Fee · Philips Medical Systems, Inc.
Key facts
| Original PMA | P160029 |
|---|---|
| Supplement number | S024 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | HeartStart HS1 Onsite Defibrillator (M5066A), HeartStart HS1 Home Defibrillator (M5068A) |
| Generic name | Over-the-counter automated external defibrillator |
| Applicant | Philips Medical Systems, Inc. |
| Product code | NSA |
| Received date | Jan 23, 2024 |
| Decision date | Feb 21, 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: