PMA P160015S028

Device: AED 3; CPR Uni-Padz
Applicant: ZOLL Medical Corporation
PMA number: P160015
Supplement: S028
Product code: MKJ
Decision date: 2026-07-16
Classification: Cardiovascular
Generic name: Automated external defibrillators (non-wearable)
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in the approval order for P160015/S001.

Current openFDA PMA Record#

Device: AED 3; CPR Uni-Padz
Applicant: ZOLL Medical Corporation
PMA number: P160015
Supplement: S028
Product code: MKJ
Generic name: Automated external defibrillators (non-wearable)
Decision date: 2026-07-16
Decision code: APPR
Date received: 2026-06-01
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) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in the approval order for P160015/S001.