FDA.reportPublic FDA data

PMA P160008S012

Device
HeartSine samaritan Public Access Automated External Defibrillators and Accessories
Applicant
Heartsine Technologies, Ltd.
PMA number
P160008
Supplement
S012
Product code
MKJ
Decision date
2020-07-17
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Addition of a modified tooling for the assembly of the pogo pin components used in the manufacture of SAM350P, SAM360P, and SAM450P AEDs and accessories.

Current openFDA PMA Record#

Device
HeartSine samaritan Public Access Automated External Defibrillators and Accessories
Applicant
Heartsine Technologies, Ltd.
PMA number
P160008
Supplement
S012
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2020-07-17
Decision code
OK30
Date received
2020-06-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a modified tooling for the assembly of the pogo pin components used in the manufacture of SAM350P, SAM360P, and SAM450P AEDs and accessories.