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Product Approval Information - Licensing Action

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Proper name: Autologous Cultured Chondrocytes
Tradename: Carticel
Manufacturer: Genzyme Biosurgery, Cambridge, MA, License #1659
Processing Change: To utilize the BacT/Alert automated microbial detection system for the release of Carticel product based on interim negative results at approximately day 3 of a 14-day assay
Approval Date: 2/17/2004
Type of submission: Biologics license application supplement

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Approval Letter - (Text)

 

Updated May 14, 2004
 
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