Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: COSEAL SURGICAL SEALANT (COSEAL)
• Generic Name: Sealant, polymerizing
• Applicant: Angiotech Medical Device Technologies; 3600 S.W 47th Ave.; Gainesville, FL 32608
• PMA Number: P010022
• Date Received: 04/12/2001
• Decision Date: 12/14/2001
• Withdrawal Date: 03/15/2012
• Product Code: NBE
• Docket Number: 02M-0076
• Notice Date: 02/25/2002
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE COSEAL SURGICAL SEALANT. THIS DEVICE IS INDICATED FOR USE IN VASCULAR RECONSTRUCTIONS TO ACHIEVE ADJUNCTIVE HEMOSTASIS BY MECHANICALLY SEALING AREAS OF LEAKAGE.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S001 S002 S003