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 22 CHANNEL COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P840024 |
Supplement Number | S071 |
Date Received | 09/25/1997 |
Decision Date | 06/26/1998 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for anew sterilization facility located at cochlear limited, 14 mars road, lane cove, new south wales 2066, australia. |
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