OXFORD PATIAL KNEE SYSTEM
FDA premarket approval P010014/S036 · decided 2012-08-02
Approval details
- PMA number
- P010014
- Supplement
- S036
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OXFORD PATIAL KNEE SYSTEM
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2012-07-02
- Decision date
- 2012-08-02
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR UPDATES TO THE PACKAGE INSERT WHICH INCLUDED THE FOLLOWING: STRENGTHENING AND CLARIFICATION OF THE IMPORTANCE OF FOLLOWING THE SURGICAL TECHNIQUE, ADDITIONAL WORDING TO CLARIFY A PRECAUTION TO THE END USER, EXPANDED LANGUAGE FOR A POSSIBLE ADVERSE EVENT ABOUT FOREIGN MATERIAL SENSITIVITY AND REFORMATTING OF THE MAGNETIC RESONANCE (MR) SECTION.
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