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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 9 of 9 Results
productcode MHE PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
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Device
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Applicant
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PMA
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Decision
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Nucleus Auditory Brainstem Implant System Cochlear Americas P000015 S033 09/10/2018
Nucleus Auditory Brainstem Implant Cochlear Americas P000015 S027 06/13/2018
Nucleus 24 Auditory Brainstem Implant Cochlear Americas P000015 S032 05/11/2018
Nucleus AB1541 Auditory Brainstem Implant Cochlear Americas P000015 S031 03/16/2018
Nucleus Auditory Brainstem Implant System Cochlear Americas P000015 S030 03/02/2018
Nucleus Auditory Brainstem Implant System Cochlear Americas P000015 S026 02/14/2018
Nucleus 24 Cochlear Implant System Cochlear Americas P970051 S170 02/14/2018
Nucleus Auditory Brainstem Implant System Cochlear Americas P000015 S028 02/01/2018
Nucleus Auditory Brainstem Implant System Cochlear Americas P000015 S029 02/01/2018
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