PMA P160033S005
- Device
- Powerheart® G5 AED
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160033
- Supplement
- S005
- Product code
- MKJ
- Decision date
- 2021-02-02
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- New manufacturing equipment and alternate material for printed circuit boards.
Current openFDA PMA Record#
- Device
- Powerheart® G5 AED
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160033
- Supplement
- S005
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2021-02-02
- Decision code
- OK30
- Date received
- 2021-01-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New manufacturing equipment and alternate material for printed circuit boards.