Approval for the heartstart onsite defibrillator (model m6066a) and heartstart home defibrillator (model m5068a). The heartstart onsite defibrillator (m5066a) is indicated for use on potential victims of sudden cardiac arrest with the following symptoms:• unconsciousness; and • absence of normal breathing. The heartstart onsite (model m5066a) is indicated for adults over 55 pounds (25 kg). It is also indicated for infants and children under 55 lbs (25 kg) or 8 years old when used with the optional infant/child smart pads. If infant/child smart pads are not available, or you are uncertain of the child’s age or weight, proceed with treatment using adult smart pads. The heartstart home defibrillator (m5068a) is indicated for use on potential victims of cardiac arrest with the following symptoms: • unconsciousness; and • absence of normal breathing. The heartstart home (m5068a) is indicated for adults over 55 pounds (25 kg). They are also indicated for infants and children under 55 lbs (25 kg) or 8 years old when used with the optional infant/child smart pads. If infant/child smart pads are not available, or you are uncertain of the child’s age or weight, proceed with treatment using adult smart pads.
| Device | HeartStart OnSite Defibrillator (Model M6066A) and HeartStart Home Defibrillator (Model M5068A) |
| Classification Name | Over-the-counter Automated External Defibrillator |
| Generic Name | Over-the-counter Automated External Defibrillator |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. |
| Date Received | 2016-07-29 |
| Decision Date | 2019-06-06 |
| PMA | P160029 |
| Supplement | S |
| Product Code | NSA |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PHILIPS MEDICAL SYSTEMS, INC. 22100 Bothell -everett Hwy bothell, WA 98021 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160029 | Original Filing | |
| S017 | 2022-07-05 | 30-day Notice |
| S016 | 2022-05-11 | 30-day Notice |
| S015 | 2022-02-22 | 30-day Notice |
| S014 | ||
| S013 | 2021-07-30 | 30-day Notice |
| S012 | 2021-05-21 | 30-day Notice |
| S011 | 2021-03-22 | 30-day Notice |
| S010 | 2021-02-23 | 30-day Notice |
| S009 | 2021-01-21 | 30-day Notice |
| S008 | ||
| S007 | 2020-11-16 | 30-day Notice |
| S006 | 2020-07-31 | 30-day Notice |
| S005 | 2020-07-06 | 30-day Notice |
| S004 | 2020-06-19 | 30-day Notice |
| S003 | ||
| S002 | 2019-11-18 | 30-day Notice |
| S001 |