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Device | HeartSine samaritan® Public Access Automated External Defibrillators 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 | S019 |
Date Received | 03/28/2022 |
Decision Date | 05/31/2022 |
Product Code |
MKJ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the manufacturing of the SAM 350P, SAM 360P and SAM 450P defibrillators and accessory Pad-Paks using certain lead-free components. |