PMA P000015S006

Device: NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S006
Product code: MCM
Decision date: 2005-03-30
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: CHANGE OF SUPPLIER FOR THREE SILICONE PRODUCTS (SILICONE HCRP 50, SILICONE LSR 30, AND RTV SILICONE ADHESIVE) AND CHANGE THE CATALYST IN TWO ADDITIONAL SILICONE PRODUCTS (MED4515 & MED4516).

Current openFDA PMA Record#

Device: NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P000015
Supplement: S006
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2005-03-30
Decision code: OK30
Date received: 2005-03-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE OF SUPPLIER FOR THREE SILICONE PRODUCTS (SILICONE HCRP 50, SILICONE LSR 30, AND RTV SILICONE ADHESIVE) AND CHANGE THE CATALYST IN TWO ADDITIONAL SILICONE PRODUCTS (MED4515 & MED4516).