PMA P160029S008
- Device
- HeartStart OnSite and Home Defibrillator
- Applicant
- Philips Medical Systems, Inc.
- Product code
- NSA
- Decision date
- 2021-04-06
- Generic name
- Over-the-counter automated external defibrillator
- Approval order statement
- Approval for a change in speaker component for the HeartStart FRx, OnSite, and Home Defibrillator devices.
Current openFDA PMA Record#
- Device
- HeartStart OnSite and Home Defibrillator
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160029
- Supplement
- S008
- Product code
- NSA
- Generic name
- Over-the-counter automated external defibrillator
- Decision date
- 2021-04-06
- Decision code
- APPR
- Date received
- 2021-01-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in speaker component for the HeartStart FRx, OnSite, and Home Defibrillator devices.