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. |
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Device | NUCLEUS COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P970051 |
Supplement Number | S103 |
Date Received | 12/24/2012 |
Decision Date | 03/21/2013 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR TE STERILE SILICONE TEMPLATE (SST) AS A SINGLE USE SURGICAL TOOL TO HELP CHECK THE SIZE OF THE PERIOSTEAL POCKET, THE SHAPE AND DEPTH OF THE IMPLANT WELL, AND APPROPRIATE POSITIONS FOR TIE-DOWN HOLES DURING THE IMPLANT SURGICAL PROCEDURE. |
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