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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: To narrow the indication to second line therapy, for use in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure
Approval Date: 3/2/2000
Type of submission: Biologics license application supplement

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Approval Letter - (PDF), (Text)

Label - (PDF), (Text)

Manufacturer Notice of Change in Product Labeling

 

Updated December 10, 2001
 
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