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.
New manufacturing equipment and alternate material for printed circuit boards
| Device | Powerheart® G5 AED |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | ZOLL Medical Corporation |
| Date Received | 2021-01-08 |
| Decision Date | 2021-02-02 |
| PMA | P160033 |
| Supplement | S005 |
| 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 | ZOLL Medical Corporation 269 Mill Road chelmsford, MA 01824 |
| 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 |