PMA P160015S029

Device: AED 3 Defibrillator with Uni-Padz
Applicant: ZOLL Medical Corporation
PMA number: P160015
Supplement: S029
Product code: MKJ
Decision date: 2026-10-16
Classification: Cardiovascular
Generic name: Automated external defibrillators (non-wearable)
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above to replace the original PAS protocol. 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 Defibrillator with Uni-Padz
Applicant: ZOLL Medical Corporation
PMA number: P160015
Supplement: S029
Product code: MKJ
Generic name: Automated external defibrillators (non-wearable)
Decision date: 2026-10-16
Decision code: APPR
Date received: 2026-09-18
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above to replace the original PAS protocol. The PAS protocol has been submitted to comply with the conditions of approval outlined in the approval order for P160015/S001.