PMA P160033S004
- Device
- Powerheart® G3, G3 Plus and G5 AEDs
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160033
- Supplement
- S004
- Product code
- MKJ
- Decision date
- 2019-08-20
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Update to the Smart Packing Software to automate a verification step.
Current openFDA PMA Record#
- Device
- Powerheart® G3, G3 Plus and G5 AEDs
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160033
- Supplement
- S004
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2019-08-20
- Decision code
- OK30
- Date received
- 2019-08-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the Smart Packing Software to automate a verification step.