TMJ FOSSA EMINENCE PROSTHESIS SYSTEM
FDA premarket approval P000023/S003 · decided 2004-01-22
Approval details
- PMA number
- P000023
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TMJ FOSSA EMINENCE PROSTHESIS SYSTEM
- Generic name
- Joint, temporomandibular, implant
- Applicant
- Nexus CMF, LLC
- Date received
- 2002-06-20
- Decision date
- 2004-01-22
- Days to decision
- 581 days
- Decision code
- APPR
- Product code
- LZD
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Golden, CO
- Statement
- APPROVAL FOR A NEW MANUFACTURING SITE FOR THE CRYSTALCLEAR ANATOMICAL MODEL. THE SITE IS LOCATED AT TMJ IMPLANTS, INC., GOLDEN, COLORADO.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.