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Device | HeartSine samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P, and SAM 450P) and Accessories |
Generic Name | Automated external defibrillators (non-wearable) |
Regulation Number | 870.5310 |
Applicant | HeartSine Technologies, Ltd. 207 Airport Road West Belfast, Northern Ireland BT3 9 |
PMA Number | P160008 |
Supplement Number | S014 |
Date Received | 09/24/2020 |
Decision Date | 10/22/2020 |
Product Code |
MKJ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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). |