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.
Update to the smart packing software to automate a verification step.
| Device | Powerheart® G3, G3 Plus and G5 AEDs |
| Classification Name | Automated External Defibrillators (non-wearable) |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | CARDIAC SCIENCE CORPORATION |
| Date Received | 2019-08-01 |
| Decision Date | 2019-08-20 |
| PMA | P160033 |
| Supplement | S004 |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |