• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
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.
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
PMA NumberP960058
Supplement NumberS023
Date Received07/29/2002
Decision Date09/09/2002
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the commercial distribution of the clarion hifocus electrode without the positioner (model ab-5100-11a) in adults with post-lingual onset of severe-to-profound hearing loss and in children with profound hearing loss (12-months to 17-years, 11-months of age). It also requested approval of the high resolution speech processing strategy (hires software, model number ci-6055) for both patient populations.