FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implant, Cochlear
PMA: P960058
·
Supplement: S098
·
Decision May 20, 2013
Classifications
1
FEI Numbers
22
Registration Numbers
22
Basic Information
- Device Name
- Implant, Cochlear
- Trade Name
- HIRESOLUTION BIONIC EAR SYSTEM
- PMA Number
- P960058
- Supplement Number
- S098
- Device Class
- FDA Class 3
- Product Code
- MCM
- Generic Name
- Implant, cochlear
- Medical Specialty
- Unknown
- Advisory Committee
- Ear, Nose, Throat
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 20, 2013
- Date Received
- September 10, 2012
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR AN ALTERNATE ELECTRODE CONFIGURATION FOR THE HIRES 90K ADVANTAGE COCHLEAR IMPLANT DEVICE, THE "HI FOCUS MID-SCALA ELECTRODE.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MCM | Implant, Cochlear | FDA class 3 | Unknown |