Premarket Approval (PMA)

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.

• Device: 3M BRAND COCHLEAR IMPLANT SYSTEM/HOUSE DESIGN
• Generic Name: Implant, cochlear
• Applicant: Cochlear Americas; 13059 E Peakview Ave.; Centennial, CO 80111
• PMA Number: P830069
• Supplement Number: S001
• Date Received: 02/11/1985
• Decision Date: 06/17/1985
• Withdrawal Date: 03/09/2011
• Product Code: MCM
• Advisory Committee: Ear Nose & Throat
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No