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Product Approval Information - Licensing Action

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Proper name: Autologous Cultured Chondrocytes
Tradename: Carticel SM Service
Manufacturer: Genzyme Tissue Repair, Cambridge, MA, License #1233
Indication for Use: Repair of clinically significant, symptomatic cartilaginous defects of the femoral condyle (medial, lateral or trochlear) caused by acute or repetitive trauma
Approval Date: 8/22/97
Type of submission: Biologics license application

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Approval Letter - (PDF), (Text)

SBA - PDF

Label - PDF

Talk Paper

 

Updated March 16, 2001
 
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