- Device
- HeartSine samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P, and SAM 450P) and Accessories
- Applicant
- Heartsine Technologies, Ltd.
- PMA number
- P160008
- Supplement
- S014
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2020-10-22
- Decision code
- OK30
- Date received
- 2020-09-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the soldering method used for seven (7) specific plated through-hole (PTH) components from selective soldering to manual soldering and adding manual cleaning of the test point pads of the printed circuit board assembly (PCBA).