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Device | HeartSine's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) |
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 | S024 |
Date Received | 03/06/2024 |
Decision Date | 04/01/2024 |
Product Code |
MKJ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for supplemental labeling to recommend power cycling the device every three months |