PMA P910016
- Device
- Lcs(r)total Knee System
- Applicant
- DEPUY, INC.
- PMA number
- P910016
- Supplement
- S011
- Decision date
- 1999-03-04
Current openFDA PMA Record
- Device
- LCS UNI KNEE SYSTEM
- Applicant
- Depuy, Inc.
- PMA number
- P910016
- Supplement
- S015
- Product code
- MBD
- Generic name
- PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
- Decision date
- 2005-12-12
- Decision code
- APPR
- Date received
- 2005-11-10
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES IN QUALITY CONTROLS TO THE LCS PRESERVATION UNI MOBILE BEARING INSERTS APPROVED IN P910016/S012. THE CHANGES INCLUDE MODIFICATIONS TO SEVERAL MANUFACTURING PROCESS SPECIFICATIONS (MPS) FOR GAMMA VACUUM FOIL (GVF) PACKAGED PRODUCTS: 1) TO ADD PHYSICAL SEPARATION BARRIERS TO THE SEALING MACHINE TO PREVENT ADJACENT FOIL POUCHES FROM OVERLAPPING DURING THE SEALING OPERATION, AND 2) TO REQUIRE A SECOND 100% INSPECTION OF THE SEAL INTEGRITY OF EACH PACKAGE PRIOR TO SHIPMENT.