ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)
FDA premarket approval P050011/S002 · decided 2011-06-17
Approval details
- PMA number
- P050011
- Supplement
- S002
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- Baxter Healthcare Corp
- Date received
- 2010-11-03
- Decision date
- 2011-06-17
- Days to decision
- 226 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Mcgaw Park, IL
- Statement
- APPROVAL TO IMPLEMENT THE ASSAY FOR DETECTING THE AMOUNT OF PEPTIDOGLYCAN (PG) IN THE ICODEXTRIN ACTIVE PHARMACEUTICAL INGREDIENT (API).
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