PMA P100030S002

Device: ARTERX SURGICAL SEALANT,
Applicant: Baxter Healthcare Corporation
PMA number: P100030
Supplement: S002
Product code: NBE
Decision date: 2013-11-05
Classification: Sealant, Polymerizing
Generic name: Sealant, polymerizing
Approval order statement: APPROVAL TO EXTEND THE SHELF LIFE FOR ARTERX SURGICAL SEALANT FROM 12 MONTHS TO 24 MONTHS WHEN STORED AT2-8C AND TO EXTEND THE SHELF LIFE FOR THE ARTERX DELIVERY TIPS FROM 12 MONTHS TO 42 MONTHS.

Current openFDA PMA Record#

Device: ARTERX SURGICAL SEALANT,
Applicant: Baxter Healthcare Corporation
PMA number: P100030
Supplement: S002
Product code: NBE
Generic name: Sealant, polymerizing
Decision date: 2013-11-05
Decision code: APPR
Date received: 2013-09-03
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO EXTEND THE SHELF LIFE FOR ARTERX SURGICAL SEALANT FROM 12 MONTHS TO 24 MONTHS WHEN STORED AT2-8C AND TO EXTEND THE SHELF LIFE FOR THE ARTERX DELIVERY TIPS FROM 12 MONTHS TO 42 MONTHS.