PMA P160028
- Device
- HeartStart FR3 Text (861388) Defibrillator; HeartStart FR3 ECG (861389) Defibrillator
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160028
- Supplement
- S004
- Product code
- MKJ
- Decision date
- 2026-05-21
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- a new adhesive material used in the electrode pads.
Current openFDA PMA Record#
- Device
- HeartStart FR3 Text (861388) Defibrillator; HeartStart FR3 ECG (861389) Defibrillator
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160028
- Supplement
- S007
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2026-05-21
- Decision code
- APPR
- Date received
- 2026-02-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- a new adhesive material used in the electrode pads.