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 battery end of line test equipment for the hs1 and frx primary battery, and the frx aviation battery at the contract manufacturer
| Device | HeartStart OnSite Defibrillator and HeartStart Home Defibrillator |
| Generic Name | Over-the-counter Automated External Defibrillator |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. |
| Date Received | 2021-05-21 |
| Decision Date | 2021-06-15 |
| PMA | P160029 |
| Supplement | S012 |
| 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 Hwy bothell, WA 98021 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160029 | Original Filing | |
| S017 | 2022-07-05 | 30-day Notice |
| S016 | 2022-05-11 | 30-day Notice |
| S015 | 2022-02-22 | 30-day Notice |
| S014 | ||
| S013 | 2021-07-30 | 30-day Notice |
| S012 | 2021-05-21 | 30-day Notice |
| S011 | 2021-03-22 | 30-day Notice |
| S010 | 2021-02-23 | 30-day Notice |
| S009 | 2021-01-21 | 30-day Notice |
| S008 | ||
| S007 | 2020-11-16 | 30-day Notice |
| S006 | 2020-07-31 | 30-day Notice |
| S005 | 2020-07-06 | 30-day Notice |
| S004 | 2020-06-19 | 30-day Notice |
| S003 | ||
| S002 | 2019-11-18 | 30-day Notice |
| S001 |