NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA premarket approval P840024/S063 · decided 1996-06-20
Approval details
- PMA number
- P840024
- Supplement
- S063
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1996-04-25
- Decision date
- 1996-06-20
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR REVISIONS TO THE WARNINGS SECTION IN THE PACAKGE INSERT AND PATIENT IDENTIFICATION CARD FOR THE NUCLEUS 22 COCHLEAR IMPLANT SYSTEM. THE REVISIONS CLARIFY THE WARNING ON THE USE OF MONOPOLAR ELECTROSURGICAL INSTRUMENTS ON IMPLANT PATIENTS AND PROVIDES USE OF MONOPOLAR ELECTROSURGICAL INSTRUMENTS ON IMPLANT PATIENTS AND PROVIDES ADDTIONIAL INSTRUCTIONS FOR THE SAFE USE OF BIPOLAR INSTRUMENTS
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