PMA P160008S001
- Device
- samaritan Public Access Automated External Defibrillators and Accessories
- Applicant
- Heartsine Technologies, Ltd.
- PMA number
- P160008
- Supplement
- S001
- Product code
- MKJ
- Decision date
- 2018-10-09
- Classification
- Automated External Defibrillators (non-wearable)
- Generic name
- Automated external defibrillators (non-wearable)
- Approval order statement
- Implementation of an alternative manufacturing process (selective soldering) for soldering through-hole components on the printed circuit board assemblies used in the SAM 350P and SAM 360P public access defibrillators.
Current openFDA PMA Record#
- Device
- samaritan Public Access Automated External Defibrillators and Accessories
- Applicant
- Heartsine Technologies, Ltd.
- PMA number
- P160008
- Supplement
- S001
- Product code
- MKJ
- Generic name
- Automated external defibrillators (non-wearable)
- Decision date
- 2018-10-09
- Decision code
- OK30
- Date received
- 2018-09-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an alternative manufacturing process (selective soldering) for soldering through-hole components on the printed circuit board assemblies used in the SAM 350P and SAM 360P public access defibrillators.