COCHLEAR C1500 SERIES IMPLANTS
FDA premarket approval P970051/S131 · decided 2015-11-19
Approval details
- PMA number
- P970051
- Supplement
- S131
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COCHLEAR C1500 SERIES IMPLANTS
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2015-05-18
- Decision date
- 2015-11-19
- Days to decision
- 185 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR THE MANUFACTURING SPECIFICATION TOLERANCES FOR THREE AREAS OF THE TOP SHELL (DEPTH, DOMING IN CENTER, AND FLATNESS OF CHASSIS MATING EDGE), A COMPONENT OF THE IMPLANT CASING.
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