Approval for a cybersecurity software update to prevent corruption or modification of the powerheart g5 aed software executables.
| Device | Powerheart G5 AED |
| Classification Name | Automated External Defibrillators (non-wearable) |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | CARDIAC SCIENCE CORPORATION |
| Date Received | 2018-12-17 |
| Decision Date | 2018-12-20 |
| PMA | P160033 |
| Supplement | S001 |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CARDIAC SCIENCE CORPORATION n7 W22025 Johnson Dr suite 100 waukesha, WI 53186 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160033 | | Original Filing |
| S008 |
2021-06-04 |
30-day Notice |
| S007 | | |
| S006 | | |
| S005 |
2021-01-08 |
30-day Notice |
| S004 |
2019-08-01 |
30-day Notice |
| S003 | | |
| S002 |
2019-04-29 |
Normal 180 Day Track |
| S001 |
2018-12-17 |
Real-time Process |
NIH GUDID Devices