FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implant, Hearing, Active, Middle Ear, Partially Implanted
PMA: P010023
·
Supplement: S002
·
Decision Oct 8, 2009
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Implant, Hearing, Active, Middle Ear, Partially Implanted
- Trade Name
- MAXUM SYSTEM
- PMA Number
- P010023
- Supplement Number
- S002
- Device Class
- FDA Class 3
- Product Code
- MPV
- Generic Name
- Implant, hearing, active, middle ear, partially implanted
- Medical Specialty
- Unknown
- Advisory Committee
- Ear, Nose, Throat
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 8, 2009
- Date Received
- August 19, 2009
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL TO CHANGE THE LABELING WITH A NEW PRODUCT NAME, MAXUM SYSTEM
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 |
|---|---|---|---|
| MPV | Implant, Hearing, Active, Middle Ear, Partially Implanted | FDA class 3 | Unknown |