|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 (ORIGINAL AND PRE-MIXED)|
|Applicant||ANGIOTECH MEDICAL DEVICE TECHNOLOGIES|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modified real-time stability protocols and real-time commercial lot aging protocols to include mechanical and viscosity testing.