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 Patrial 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 | S073 |
Date Received | 03/20/2018 |
Decision Date | 04/19/2018 |
Product Code |
NRA |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change the laboratory that is conducting microbiology tests, change the irradiator vendor used for irradiating dose verification of test samples, and change the vendor used for testing water conductivity. |
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