NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
FDA premarket approval P000015/S006 · decided 2005-03-30
Approval details
- PMA number
- P000015
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2005-03-09
- Decision date
- 2005-03-30
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- 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).
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