PMA P160015S025
- Device
- AED 3™
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160015
- Supplement
- S025
- Product code
- MKJ
- Decision date
- 2025-12-18
- Classification
- Cardiovascular
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- approval for updates to the labeling to add post-approval study results.
Current openFDA PMA Record#
- Device
- AED 3™
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160015
- Supplement
- S025
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2025-12-18
- Decision code
- APPR
- Date received
- 2025-07-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- approval for updates to the labeling to add post-approval study results.