PMA P160015S026

Device
CPR-D-padz Electrode
Applicant
ZOLL Medical Corporation
PMA number
P160015
Supplement
S026
Product code
MKJ
Decision date
2025-09-22
Classification
Cardiovascular
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
approval for a manufacturing site located at 200 Narragansett Park Drive, Rumford, RI 02916.

Current openFDA PMA Record#

Device
CPR-D-padz Electrode
Applicant
ZOLL Medical Corporation
PMA number
P160015
Supplement
S026
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2025-09-22
Decision code
APPR
Date received
2025-08-01
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval for a manufacturing site located at 200 Narragansett Park Drive, Rumford, RI 02916.