The heartstart frx defibrillator (model 861304) is indicated for use on potential victims of sudden cardiac arrest (sca) with the following symptoms:• unconsciousness, and• absence of normal breathingthe heartstart frx (model 861304) is indicated for adults over 55 pounds (25 kg). The model 861304 is also indicated for infants and children under 55 pounds (25 kg) or 0-8 years old when used with the optional infant/child key (model 989803139311). If the infant/child key is not available, or you are uncertain of the child’s age or weight, proceed using adult treatment without the infant/child key.
| Device | HeartStart FRx Defibrillator |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | Philips Medical Systems |
| Date Received | 2018-08-03 |
| Decision Date | 2020-05-11 |
| PMA | P180028 |
| Supplement | S |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Philips Medical Systems 22100 Bothell Everett Hwy bothell, WA 98021 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180028 | Original Filing | |
| S012 | 2022-02-22 | 30-day Notice |
| S011 | 2021-10-18 | 30-day Notice |
| S010 | 2021-08-30 | 30-day Notice |
| S009 | 2021-05-21 | 30-day Notice |
| S008 | 2021-05-17 | Special (immediate Track) |
| S007 | 2021-02-23 | 30-day Notice |
| S006 | 2021-01-21 | 30-day Notice |
| S005 | ||
| S004 | 2020-11-16 | 30-day Notice |
| S003 | 2020-07-31 | 30-day Notice |
| S002 | 2020-07-06 | 30-day Notice |
| S001 | 2020-06-19 | 30-day Notice |