Atlas FDA

PNQ

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Apical Closure Device
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4510
Medical specialty
Cardiovascular
Flags
Implant
FDA definition
This device is intended for closure of cardiac apical tissue.
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RecordFirmDateBuilder
Permaseal (DEN150029)Micro Interventional Devices,Inc.2016-07-27

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