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 | COCHLEAR C1500 SERIES IMPLANTS |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P970051 |
Supplement Number | S131 |
Date Received | 05/18/2015 |
Decision Date | 11/19/2015 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MANUFACTURING SPECIFICATION TOLERANCES FOR THREE AREAS OF THE TOP SHELL (DEPTH, DOMING IN CENTER, AND FLATNESS OF CHASSIS MATING EDGE), A COMPONENT OF THE IMPLANT CASING. |
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