NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (NUCLEUS 24 CONTOUR COCHLEAR IMPLANT
FDA premarket approval P970051/S014 · decided 2001-02-08
Approval details
- PMA number
- P970051
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (NUCLEUS 24 CONTOUR COCHLEAR IMPLANT
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2001-01-16
- Decision date
- 2001-02-08
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR AN EXTENSION OF THE SHELF LIFE FROM SIX (6) MONTHS TO TWO (2) YEARS.
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