FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Joint, Temporomandibular, Implant
PMA: P980052
·
Supplement: S004
·
Decision Sep 2, 2009
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Joint, Temporomandibular, Implant
- Trade Name
- PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM
- PMA Number
- P980052
- Supplement Number
- S004
- Device Class
- FDA Class 3
- Product Code
- LZD
- Generic Name
- Joint, temporomandibular, implant
- Regulation Number
- 872.3940
- Medical Specialty
- Dental
- Advisory Committee
- Dental
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 2, 2009
- Date Received
- March 3, 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 FOR MODIFIED LABELING.
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 |
|---|---|---|---|
| LZD | Joint, Temporomandibular, Implant | FDA class 3 | Dental |