FDA PMA
Approved
🇺🇸 United States
PMA: P960058
·
Supplement: S012
·
Decision Feb 2, 2000
Classifications
0
FEI Numbers
0
Registration Numbers
0
Basic Information
- Trade Name
- CLARION MULTI-STRATEGY COCHLEAR IMPLANT SYSTEM
- PMA Number
- P960058
- Supplement Number
- S012
- Advisory Committee
- Ear, Nose, Throat
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 2, 2000
- Date Received
- November 12, 1999
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Size reduction in the speech processor known as the Platinum Sound Processor.