PMA P180028S010
- Device
- HeartStart FRx Defibrillator (861304)
- Applicant
- Philips Medical Systems
- PMA number
- P180028
- Supplement
- S010
- Product code
- MKJ
- Decision date
- 2021-09-24
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Change to the hardliner sealing process for the SMART Padz II.
Current openFDA PMA Record#
- Device
- HeartStart FRx Defibrillator (861304)
- Applicant
- Philips Medical Systems
- PMA number
- P180028
- Supplement
- S010
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2021-09-24
- Decision code
- OK30
- Date received
- 2021-08-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the hardliner sealing process for the SMART Padz II.