NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
FDA premarket approval P890027/S032 · decided 1996-06-13
Approval details
- PMA number
- P890027
- Supplement
- S032
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1996-04-25
- Decision date
- 1996-06-13
- Days to decision
- 49 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 WARNING SECTION IN THE PACKAGE 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 ADD'L INSTRUCTIONS FOR THE SAFE USE OF BIPOLAR INSTRUMENTS
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