FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implant, Hearing, Active, Middle Ear, Partially Implanted
PMA: P010023
·
Supplement: S001
·
Decision Sep 4, 2002
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Implant, Hearing, Active, Middle Ear, Partially Implanted
- Trade Name
- SOUNDTEC DIRECT IPCA SYSTEM
- PMA Number
- P010023
- Supplement Number
- S001
- 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
- September 4, 2002
- Date Received
- November 21, 2001
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE SOUNDTEC DIRECT IPCA SYSTEM. THE INDICATIONS FOR USE HAS NOT BEEN CHANGED.
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 |