- Device
- HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S019
- Product code
- NSA
- Generic name
- Over-the-counter automated external defibrillator
- Decision date
- 2023-04-03
- Decision code
- APPR
- Date received
- 2023-01-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design changes including hardware changes for compliance with international restricted material regulations.