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Heart-Valve, Mechanical — On-X Life Technologies, Inc. (PMA P000037)

Heart-Valve, Mechanical — On-X Life Technologies, Inc. (PMA P000037) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Heart-Valve, Mechanical; Applicant: On-X Life Technologies, Inc.; Clearance track: PMA.

Device nameHeart-Valve, Mechanical
ApplicantOn-X Life Technologies, Inc.
Clearance trackPMA
Submission numberP000037
DecisionAPPR
Decision date2015-02-09
Date received2014-08-27
Product codeLWQ
Device class3
Medical specialtyUnknown
Applicant locationGA
SourceopenFDA device

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