|
Device | PREVELEAK SURGICAL SEALANT |
Generic Name | Sealant, polymerizing |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P100030 |
Supplement Number | S004 |
Date Received | 05/22/2014 |
Decision Date | 07/31/2014 |
Product Code |
NBE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A PRODUCT TRADE NAME CHANGE FROM ARTERX® SURGICAL SEALANT TO PREVELEAK SURGICAL SEALANT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PREVELEAK SURGICAL SEALANT AND IS INDICATED FOR USE IN VASCULAR RECONSTRUCTIONS TO ACHIEVE ADJUNCTIVE HEMOSTASIS BY MECHANICALLY SEALING AREAS OF LEAKAGE. |