PMA P160022S028
- Device
- X Series Advanced Devices
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S028
- Product code
- MKJ
- Decision date
- 2021-05-19
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- X Series Advanced Devices
- Applicant
- ZOLL Medical Corporation
- PMA number
- P160022
- Supplement
- S028
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2021-05-19
- Decision code
- APPR
- Date received
- 2021-04-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.