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PREVELEAK SURGICAL SEALANT

FDA premarket approval P100030/S004 · decided 2014-07-31

Approval details

PMA number
P100030
Supplement
S004
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
PREVELEAK SURGICAL SEALANT
Generic name
Sealant, polymerizing
Applicant
Baxter Healthcare Corporation
Date received
2014-05-22
Decision date
2014-07-31
Days to decision
70 days
Decision code
APPR
Product code
NBE
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Deerfield Lake, IL
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.

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