www.fdanews.com/articles/80928-fda-issues-approvable-letter-for-hip-device
FDA ISSUES APPROVABLE LETTER FOR HIP DEVICE
September 15, 2005
Biomet has received an approvable letter from the FDA for its ceramic-on-ceramic hip system, used as a hip replacement.
The firm said it expects to introduce the Biomet C2a-Taper Acetabular System immediately following the receipt of a final approval order, which Biomet projects will be issued by the end of the year. Biomet is sourcing the C2a ceramic head and ceramic liner from CeramTec AG.