PMA P010014S036
- Device
- OXFORD PATIAL KNEE SYSTEM
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S036
- Product code
- NRA
- Decision date
- 2012-08-02
- Classification
- Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Approval order 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.
Current openFDA PMA Record#
- Device
- OXFORD PATIAL KNEE SYSTEM
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S036
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2012-08-02
- Decision code
- APPR
- Date received
- 2012-07-02
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.