INTRODUCTION CP900 SERIES RECHARGEABLE BATTERIES (A29 AND A30)
FDA premarket approval P970051/S112 · decided 2013-12-20
Approval details
- PMA number
- P970051
- Supplement
- S112
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTRODUCTION CP900 SERIES RECHARGEABLE BATTERIES (A29 AND A30)
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2013-09-26
- Decision date
- 2013-12-20
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR INTRODUCTION OF THE RECHARGEABLE BATTERIES (A29 ANDA30) INTENDED FOR USE WITH THE CP900 SERIES OF SOUND PROCESSOR (CP910 AND CP920).
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