Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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.
 
DeviceNUCLEUS HYBRID L24 IMPLANT SYSTEM
Generic NameCochlear implant with combined electrical stimulation and acoustic amplification
ApplicantCochlear Americas
10350 Park Meadows Drive
Centennial, CO 80124
PMA NumberP130016
Supplement NumberS002
Date Received04/02/2014
Decision Date07/01/2014
Product Code PGQ 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN MR INDICATION AT 1.5 TESLA UNDER SPECIFIC SCANNING CONDITIONS WITH THE MAGNET SURGICALLY REMOVED PRIOR TO THE MR SCAN, FOR THE HYBRID L24 IMPLANT SYSTEM.
-
-