PMA P160022S018

Device
X Series and Propaq MD
Applicant
ZOLL Medical Corporation
PMA number
P160022
Supplement
S018
Product code
MKJ
Decision date
2020-06-11
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Add an additional manufacturing site for a supplier of printed circuit boards for the X Series and Propaq MD.

Current openFDA PMA Record#

Device
X Series and Propaq MD
Applicant
ZOLL Medical Corporation
PMA number
P160022
Supplement
S018
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2020-06-11
Decision code
OK30
Date received
2020-05-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Add an additional manufacturing site for a supplier of printed circuit boards for the X Series and Propaq MD.