COCHLEAR CI500 SERIES IMPLANTS
FDA premarket approval P970051/S135 · decided 2015-11-12
Approval details
- PMA number
- P970051
- Supplement
- S135
- Supplement type
- 30-Day Notice
- Trade name
- COCHLEAR CI500 SERIES IMPLANTS
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2015-10-13
- Decision date
- 2015-11-12
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- NEW SUPPLIER AND A CHANGE IN THE UPPER TOLERANCE SPECIFICATION OF THE 25 MICRON PLATINUM IRIDIUM WIRE.
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