|
Device | HeartStart OnSite Defibrillator and HeartStart Home Defibrillator |
Generic Name | Over-the-counter automated external defibrillator |
Applicant | PHILIPS MEDICAL SYSTEMS, INC. 22100 BOTHELL -EVERETT HWY BOTHELL, WA 98021 |
PMA Number | P160029 |
Supplement Number | S023 |
Date Received | 01/02/2024 |
Decision Date | 01/05/2024 |
Product Codes |
MKJ NSA |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for updates to the labeling to comply with California Proposition 65 requirements. |