PMA P960052S006

Device: DERMABOND TOPICAL SKIN ADHESIVE
Applicant: Closure Medical Corp.
PMA number: P960052
Supplement: S006
Product code: MPN
Decision date: 2003-06-13
Generic name: Tissue adhesive for the topical approximation of skin
Approval order statement: APPROVAL FOR TWO CHANGES TO THE LABELING: 1) CHANGE THE INSTRUCTIONS FOR USE TO STATE THAT TWO LAYERS OF ADHESIVE SHOULD BE APPLIED INSTEAD OF THREE LAYERS AND 2) THE ADDITION OF LANGUAGE STATING THAT THE DEVICE CAN ACT AS A BARRIER TO MICROBIAL PENETRATION WHEN INTACT.

Current openFDA PMA Record#

Device: DERMABOND TOPICAL SKIN ADHESIVE
Applicant: Closure Medical Corp.
PMA number: P960052
Supplement: S006
Product code: MPN
Generic name: Tissue adhesive for the topical approximation of skin
Decision date: 2003-06-13
Decision code: APPR
Date received: 2003-05-01
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR TWO CHANGES TO THE LABELING: 1) CHANGE THE INSTRUCTIONS FOR USE TO STATE THAT TWO LAYERS OF ADHESIVE SHOULD BE APPLIED INSTEAD OF THREE LAYERS AND 2) THE ADDITION OF LANGUAGE STATING THAT THE DEVICE CAN ACT AS A BARRIER TO MICROBIAL PENETRATION WHEN INTACT.