PMA P160028S003
- Device
- HeartStart FR3 Defibrillator
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160028
- Supplement
- S003
- Product code
- MKJ
- Decision date
- 2020-12-16
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Updates to the inspection process for various device components and sub-assemblies.
Current openFDA PMA Record#
- Device
- HeartStart FR3 Defibrillator
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P160028
- Supplement
- S003
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-12-16
- Decision code
- OK30
- Date received
- 2020-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to the inspection process for various device components and sub-assemblies.