FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implant, Hearing, Active, Middle Ear, Totally Implanted
PMA: P090018
·
Supplement: S010
·
Decision Sep 23, 2011
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Implant, Hearing, Active, Middle Ear, Totally Implanted
- Trade Name
- ESTEEM
- PMA Number
- P090018
- Supplement Number
- S010
- Device Class
- FDA Class 3
- Product Code
- OAF
- Generic Name
- Implant, hearing, active, middle ear, totally implanted
- Medical Specialty
- Unknown
- Advisory Committee
- Ear, Nose, Throat
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 23, 2011
- Date Received
- May 20, 2011
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol - OSB
- Expedited Review
- N
Advisory Committee Statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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 |
|---|---|---|---|
| OAF | Implant, Hearing, Active, Middle Ear, Totally Implanted | FDA class 3 | Unknown |