NUCLEUS COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S073 · decided 2011-09-27
Approval details
- PMA number
- P970051
- Supplement
- S073
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2011-05-19
- Decision date
- 2011-09-27
- Days to decision
- 131 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR WIDENING THE ACCEPTANCE WINDOW FOR THE INPUT FREQUENCY MANUFACTURING TEST FOR THE NUCLEUS FREEDOM BTE SPEECH PROCESSOR.
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