PMA P160026S033

Device
QUIK-COMBO® Therapy Cable
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S033
Product code
MKJ
Decision date
2022-08-16
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Updates to the suppliers jumper wire insertion process for the QUIK-COMBO therapy cable accessory.

Current openFDA PMA Record#

Device
QUIK-COMBO® Therapy Cable
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S033
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2022-08-16
Decision code
OK30
Date received
2022-07-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Updates to the suppliers jumper wire insertion process for the QUIK-COMBO therapy cable accessory.