PMA P160015S003
- Device
- AED Plus
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160015
- Supplement
- S003
- Product code
- MKJ
- Decision date
- 2020-01-24
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Additional rework process on the replacement of the surface mount capacitors utilized on the AED Plus Device Printed Circuit Board Assembly (PCBA).
Current openFDA PMA Record#
- Device
- AED Plus
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160015
- Supplement
- S003
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-01-24
- Decision code
- OK30
- Date received
- 2020-01-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional rework process on the replacement of the surface mount capacitors utilized on the AED Plus Device Printed Circuit Board Assembly (PCBA).