NUCLEUS COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S103 · decided 2013-03-21
Approval details
- PMA number
- P970051
- Supplement
- S103
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2012-12-24
- Decision date
- 2013-03-21
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR TE STERILE SILICONE TEMPLATE (SST) AS A SINGLE USE SURGICAL TOOL TO HELP CHECK THE SIZE OF THE PERIOSTEAL POCKET, THE SHAPE AND DEPTH OF THE IMPLANT WELL, AND APPROPRIATE POSITIONS FOR TIE-DOWN HOLES DURING THE IMPLANT SURGICAL PROCEDURE.
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