NUCLEUS COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S104 · decided 2013-10-23
Approval details
- PMA number
- P970051
- Supplement
- S104
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NUCLEUS COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2013-01-16
- Decision date
- 2013-10-23
- Days to decision
- 280 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES: A MODIFICATION TO THE FREEDOM SOUND PROCESSOR, A CHANGE IN THE FREEDOM BODYWORN CABLE O-RING, A CHANGE TO FREEDOM BODYWORN CABLE CLIP, A CHANGE TO THE FREEDOM BATTERY PACK, A CHANGE TO THE FREEDOM RECHARGEABLE BATTERY,AND A MODIFICATION OF THE SURGICAL TOOL KIT INSTRUCTIONS FOR THE CI24RE AND CI422 SERIES IMPLANTS.
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