FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Joint, Temporomandibular, Implant
PMA: P020016
·
Supplement: S007
·
Decision Dec 9, 2014
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Joint, Temporomandibular, Implant
- Trade Name
- TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
- PMA Number
- P020016
- Supplement Number
- S007
- Device Class
- FDA Class 3
- Product Code
- LZD
- Generic Name
- Joint, temporomandibular, implant
- Regulation Number
- 872.3940
- Medical Specialty
- Dental
- Advisory Committee
- Dental
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 9, 2014
- Date Received
- November 10, 2014
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
ELIMINATE A STEP WITHIN THE MANUFACTURING 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 |
|---|---|---|---|
| LZD | Joint, Temporomandibular, Implant | FDA class 3 | Dental |