FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implant, Cochlear
PMA: P830069
·
Supplement: S002
·
Decision May 22, 1986
Classifications
1
FEI Numbers
22
Registration Numbers
22
Basic Information
- Device Name
- Implant, Cochlear
- Trade Name
- 3M BRAND COCHLEAR IMPLANT SYSTEM/HOUSE DESIGN
- PMA Number
- P830069
- Supplement Number
- S002
- 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 22, 1986
- Date Received
- April 10, 1986
- Expedited Review
- N
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 |