PMA P160034S002
- Device
- Powerheart G3 Pro Automated External Defibrillator
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160034
- Supplement
- S002
- Product code
- MKJ
- Decision date
- 2020-03-01
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Supplier change for plastic components for the Powerheart G3 Pro AED.
Current openFDA PMA Record#
- Device
- Powerheart G3 Pro Automated External Defibrillator
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160034
- Supplement
- S002
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-03-01
- Decision code
- OK30
- Date received
- 2020-02-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Supplier change for plastic components for the Powerheart G3 Pro AED.