• 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (ADULT)
Generic Nameimplant, cochlear
Applicant
ADVANCED BIONICS CORP.
12740 san fernando rd.
sylmar, CA 91342
PMA NumberP940022
Supplement NumberS016
Date Received11/16/2000
Decision Date01/12/2001
Product Code 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 INCORPORATION OF THE SIZE-REDUCED SPEECH PROCESSOR TO BE WORN BEHIND THE EAR, KNOWN AS THE PLATINUM BTE(TM) SOUND PROCESSOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT PLATINUM BTE SOUND PROCESSOR. THE DEVICE IS INDICATED TO RESTORE A LEVEL OF AUDITORY SENSATION TO INDIVIDUALS WITH PROFOUND SENSORINEURAL DEAFNESS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE. ADULTS: 1) 18 YEARS OF AGE OR OLDER 2) PROFOUND, BILATERAL SENSORINEURAL DEAFNESS (>=90DB) 3) POSTLINGUALLY DEAFENED 4) LACK OF BENEFIT FROM APPROPRIATELY FITTED HEARING AIDS.
-
-