|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|
|Applicant||BAXTER BIO SCIENCE|
|Supplement Type||special (immediate track)|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for addition of safety related statements to the labeling.