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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Trade NameMAXUM
Classification Nameimplant, hearing, active, middle ear, partially implanted
Generic Nameimplantable middle ear hearing device
PMA NumberP010023
Supplement NumberS011
Date Received05/29/2014
Decision Date05/04/2015
Product Code
MPV[ Registered Establishments with MPV ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing the unaided air conduction threshold upper limits to 60, 70, and 85 db hl at frequencies of 250, 500, and 1000 hz, respectively, and to 100 db hl at 2000, 3000, 4000, and 6000 hz as part of the patient selection criteria.