PMA P160015S010
- Device
- AED Plus
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160015
- Supplement
- S010
- Product code
- MKJ
- Decision date
- 2021-03-09
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Eliminate redundant shock testing during manufacture of the AED Plus.
Current openFDA PMA Record#
- Device
- AED Plus
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160015
- Supplement
- S010
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2021-03-09
- Decision code
- OK30
- Date received
- 2021-02-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Eliminate redundant shock testing during manufacture of the AED Plus.