|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||COSEAL SURGICAL SEALANT & ACCESSORIES|
|Applicant||BAXTER HEALTHCARE CORP.|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the labeling to address safety-related information to bring the labeling into compliance with the european medical device directive mdd 2007/47/ec.