• 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.
 
DeviceNUCLEUS COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
Cochlear Americas
13059 east peakview avenue
centennial, CO 80111
PMA NumberP970051
Supplement NumberS091
Date Received07/13/2012
Decision Date05/28/2013
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 aqua accessory for the nucleus cochlear implant system. The aqua accessory is a water resistant pouch that is sealable at one end, and holds the external nucleus 5 cp810 sound processor and coil. It may be used for up to an hour to keep the external components dry during use in water (e. G. , swimming). The aqua accessory is intended for unilateral or bilateral use by cochlear implant recipients who have the ability to notify a caregiver or the ability to remove the device on their own, if the device becomes hot or if there is a change in sound quality.
-
-