This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for updates to the powerheart aed g5 device.
| Device | Powerheart G5 Automated External Defibrillator |
| Classification Name | Automated External Defibrillators (non-wearable) |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | CARDIAC SCIENCE CORPORATION |
| Date Received | 2019-04-29 |
| Decision Date | 2019-07-25 |
| PMA | P160033 |
| Supplement | S002 |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| 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 |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00812394021505 | P160033 | 000 |
| 00812394023295 | P160033 | 000 |
| 00812394023288 | P160033 | 000 |
| 00812394023271 | P160033 | 000 |
| 00812394023219 | P160033 | 000 |
| 00812394023202 | P160033 | 000 |
| 00812394023189 | P160033 | 000 |
| 00812394023172 | P160033 | 000 |
| 00812394023301 | P160033 | 000 |
| 00847946046200 | P160033 | 000 |
| 00847946046194 | P160033 | 000 |
| 00847946046187 | P160033 | 000 |
| 00812394023318 | P160033 | 000 |
| 00812394023325 | P160033 | 000 |
| 00812394023332 | P160033 | 000 |
| 00812394023349 | P160033 | 000 |
| 00812394023158 | P160033 | 004 |
| 00812394023141 | P160033 | 004 |
| 00812394023134 | P160033 | 004 |
| 00812394023127 | P160033 | 004 |
| 00812394023110 | P160033 | 004 |
| 00812394023103 | P160033 | 004 |
| 00812394023097 | P160033 | 004 |
| 00812394022779 | P160033 | 004 |
| 00812394022243 | P160033 | 004 |
| 00812394023165 | P160033 | 004 |