The models 861388 and 861389 are indicated for use by trained responders to treat ventricular fibrillation (vf), the most common cause of sudden cardiac arrest (sca), and pulseless ventricular tachycardias (vts). The models 861388 and 861389 are used with the smartpads iii or dp defibrillator pads applied to potential victims of sca with the following symptoms: • unresponsiveness• absence of normal breathing• absence of pulse or signs of circulationthe models 861388 and 861389 are intended for adults and children over 55 pounds (25 kg) or greater than 8 years old. The models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 0-8 years old when used with the optional infant/child key. If the infant/child key is not available, or you are uncertain of the child’s age or weight, do not delay treatment.
| Device | Philips HeartStart FR3 Defibrillator |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. |
| Date Received | 2016-07-29 |
| Decision Date | 2020-05-11 |
| PMA | P160028 |
| Supplement | S |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PHILIPS MEDICAL SYSTEMS, INC. 22100 Bothell Everett Highway bothell, WA 98021 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160028 | Original Filing | |
| S004 | 2021-05-17 | Special (immediate Track) |
| S003 | 2020-11-16 | 30-day Notice |
| S002 | ||
| S001 | 2020-07-06 | 30-day Notice |