OXFORD PARTIAL KNEE SYSTEM
FDA premarket approval P010014/S028 · decided 2011-01-07
Approval details
- PMA number
- P010014
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OXFORD PARTIAL KNEE SYSTEM
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2010-11-09
- Decision date
- 2011-01-07
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR CHANGES TO THE PACKAGE INSERT, INCLUDING THE ADDITION OF MR CONDITIONAL LABELING AND THE ASSOCIATED MR CONDITIONS OF USE.
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