NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S052 · decided 2009-12-10
Approval details
- PMA number
- P970051
- Supplement
- S052
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2009-07-22
- Decision date
- 2009-12-10
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR A NUMBER OF MANUFACTURING CHANGES TO INCLUDE: 1) COSMETIC CHANGES TO IMPROVE THE ADHESION OF THE PAINT TO THE BATTERY CAN; 2) HOUSING CHANGES TO IMPROVE THE DURABILITY OF THE BATTERY AND TO INCREASE THE STRENGTH OF THE CAN; AND 3) CHANGES IN THE WELDING PROCESS TO IMPROVE ULTRASONIC WELD STRENGTH AND TO REDUCE WELD FAILURES.
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