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.
Changes to the inspection procedure for components and sub-assemblies used to build the heartstart family of defibrillators.
| Device | HeartStart FR3 Defibrillator |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. |
| Date Received | 2020-07-06 |
| Decision Date | 2020-08-03 |
| PMA | P160028 |
| Supplement | S001 |
| 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 | PHILIPS MEDICAL SYSTEMS, INC. 22100 Bothell Everett Highway bothell, WA 98021 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160028 | Original Filing | |
| S004 | 2021-05-17 | Special (immediate Track) |
| S003 | 2020-11-16 | 30-day Notice |
| S002 | ||
| S001 | 2020-07-06 | 30-day Notice |