Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: 3M BRAND COCHLEAR IMPLANT SYSTEM/HOUSE DESIGN
• Generic Name: Implant, cochlear
• Applicant: Cochlear Americas; 13059 EAST PEAKVIEW AVENUE; Centennial, CO 80111
• PMA Number: P830069
• Date Received: 10/14/1983
• Decision Date: 11/26/1984
• Withdrawal Date: 03/09/2011
• Product Code: MCM
• Docket Number: 84M-0395
• Notice Date: 12/24/1984
• Advisory Committee: Ear Nose & Throat
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S001 S002