Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | OXFORD PATIAL KNEE SYSTEM |
Generic Name | Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing |
Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581-0587 |
PMA Number | P010014 |
Supplement Number | S036 |
Date Received | 07/02/2012 |
Decision Date | 08/02/2012 |
Product Code |
NRA |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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