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: GELSEAL TM TRIAXIAL VASCULAR GRAFT
• Generic Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Regulation Number: 870.3450
• Applicant: CARBOMEDICS, INC.; 1300-D EAST ANDERSON LN.; AUSTIN, TX 78752
• PMA Number: P890045
• Date Received: 08/21/1989
• Decision Date: 01/11/1993
• Reclassified Date: 05/10/2001
• Product Code: MAL
• Docket Number: 93M-0023
• Notice Date: 05/03/1993
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls
• Supplements: S001 S003 S005 S006