PMA P050011S002

Device: ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)
Applicant: Baxter Healthcare Corp
PMA number: P050011
Supplement: S002
Product code: MCN
Decision date: 2011-06-17
Classification: Barrier, Absorbable, Adhesion
Generic name: Barrier, absorbable, adhesion
Approval order statement: APPROVAL TO IMPLEMENT THE ASSAY FOR DETECTING THE AMOUNT OF PEPTIDOGLYCAN (PG) IN THE ICODEXTRIN ACTIVE PHARMACEUTICAL INGREDIENT (API).

Current openFDA PMA Record#

Device: ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)
Applicant: Baxter Healthcare Corp
PMA number: P050011
Supplement: S002
Product code: MCN
Generic name: Barrier, absorbable, adhesion
Decision date: 2011-06-17
Decision code: APPR
Date received: 2010-11-03
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO IMPLEMENT THE ASSAY FOR DETECTING THE AMOUNT OF PEPTIDOGLYCAN (PG) IN THE ICODEXTRIN ACTIVE PHARMACEUTICAL INGREDIENT (API).