• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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.
 
Trade NameNUCLEUS 24 COCHLEAR IMPLANT SYSTEM (CI24R & CI24RE MODELS)
Classification Nameimplant, cochlear
Generic Namenucleus 24 cochlear implant system (softip)
ApplicantCOCHLEAR AMERICAS
PMA NumberP970051
Supplement NumberS036
Date Received01/24/2006
Decision Date02/27/2006
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of three manufacturing process changes for ci24r and ci24re model cochlear implants powder injection-moulded (pim) ceramic feedthrough assembly.
-
-