PMA P180028S018
- Device
- HeartStart FRx Defibrillator
- Applicant
- Philips Medical Systems
- PMA number
- P180028
- Supplement
- S018
- Product code
- MKJ
- Decision date
- 2026-02-02
- Classification
- Cardiovascular
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- an update from the current manual manufacturing method to a semi-automated manufacturing method
Current openFDA PMA Record#
- Device
- HeartStart FRx Defibrillator
- Applicant
- Philips Medical Systems
- PMA number
- P180028
- Supplement
- S018
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2026-02-02
- Decision code
- OK30
- Date received
- 2026-01-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an update from the current manual manufacturing method to a semi-automated manufacturing method