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 updating the ifu for the frx and fr3 infant/child keys safety alert from caution to warning.
| Device | HeartStart FRx Defibrillator |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | Philips Medical Systems |
| Date Received | 2021-05-17 |
| Decision Date | 2021-06-15 |
| PMA | P180028 |
| Supplement | S008 |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Philips Medical Systems 22100 Bothell Everett Hwy bothell, WA 98021 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180028 | Original Filing | |
| S012 | 2022-02-22 | 30-day Notice |
| S011 | 2021-10-18 | 30-day Notice |
| S010 | 2021-08-30 | 30-day Notice |
| S009 | 2021-05-21 | 30-day Notice |
| S008 | 2021-05-17 | Special (immediate Track) |
| S007 | 2021-02-23 | 30-day Notice |
| S006 | 2021-01-21 | 30-day Notice |
| S005 | ||
| S004 | 2020-11-16 | 30-day Notice |
| S003 | 2020-07-31 | 30-day Notice |
| S002 | 2020-07-06 | 30-day Notice |
| S001 | 2020-06-19 | 30-day Notice |