FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Implant, Hearing, Active, Middle Ear, Partially Implanted
PMA: P010023
·
Supplement: S008
·
Decision Mar 2, 2011
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
- S008
- 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
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- March 2, 2011
- Date Received
- December 21, 2010
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
CHANGE TO THE IPC SHELL FABRICATION PROCESS.
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 |