- Device
- HeartStart OnSite Defibrillator and HeartStart Home Defibrillator
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S023
- Product code
- NSA
- Generic name
- Over-the-counter automated external defibrillator
- Decision date
- 2024-01-05
- Decision code
- APPR
- Date received
- 2024-01-02
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for updates to the labeling to comply with California Proposition 65 requirements.