PMA P100030S004

Device: PREVELEAK SURGICAL SEALANT
Applicant: Baxter Healthcare Corporation
PMA number: P100030
Supplement: S004
Product code: NBE
Decision date: 2014-07-31
Classification: Sealant, Polymerizing
Generic name: Sealant, polymerizing
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.

Current openFDA PMA Record#

Device: PREVELEAK SURGICAL SEALANT
Applicant: Baxter Healthcare Corporation
PMA number: P100030
Supplement: S004
Product code: NBE
Generic name: Sealant, polymerizing
Decision date: 2014-07-31
Decision code: APPR
Date received: 2014-05-22
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.