ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION
FDA premarket approval P050011 · decided 2006-07-28
Approval details
- PMA number
- P050011
- Trade name
- ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- Baxter Healthcare Corp
- Date received
- 2005-03-16
- Decision date
- 2006-07-28
- Days to decision
- 499 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Mcgaw Park, IL
- Statement
- APPROVAL FOR THE ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION. THE DEVICE IS INDICATED FOR USE INTRAPERIOTONEALLY AS AN ADJUNCT TO GOOD SURGICAL TECHNIQUE FOR THE REDUCTION OF POST-SURGICAL ADHESIONS IN PATIENTS UNDERGOING GYNECOLOGICAL LAPAROSCOPIC ADHESIOLYSIS.
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