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ADEPT Adhesion Reduction Solution

FDA PMA

Class III (US FDA PMA)

PMA P050011

by Baxter Healthcare Corp

Identity

Trade Name
ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION FDA PMA
Generic Name
Barrier, absorbable, adhesion FDA PMA

Identifiers

PMA Number
P050011 FDA PMA
FDA Product Code
MCN FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Obstetrics/Gynecology FDA PMA
FDA Decision
APPR Approved FDA PMA

The ADEPT Adhesion Reduction Solution is an absorbable barrier indicated as a Class III medical device. It is designed to reduce post-surgical adhesions when applied intraperitoneally as an adjunct to surgical technique during gynecological laparoscopic adesiolysis procedures.

This solution is supplied as a sterile, single-use product and is regulated under an FDA Premarket Approval (PMA). It is intended for intraoperative use in surgical settings and requires adherence to sterile handling protocols. The device is authorised under PMA number P050011 and falls under the product code MCN for obstetrics/gynecology applications.

Frequently asked questions

What is the ADEPT Adhesion Reduction Solution specifically designed to do during surgery, and how is it applied?

The ADEPT Adhesion Reduction Solution is designed to reduce post-surgical adhesions when applied intraperitoneally as an adjunct to surgical technique. It is intended for use during gynecological laparoscopic adesiolysis procedures, meaning it is applied inside the abdominal cavity during surgery to help prevent adhesions from forming after the procedure.

Is the ADEPT Adhesion Reduction Solution reusable or single-use, and what precautions should be taken when handling it?

The ADEPT Adhesion Reduction Solution is supplied as a sterile, single-use product. Due to its sterile nature, it must be handled using strict sterile protocols to maintain its integrity and ensure patient safety during intraoperative use.

What concentration of the active ingredient is present in the ADEPT Adhesion Reduction Solution, and what is its trade name?

The ADEPT Adhesion Reduction Solution contains 4% Icodextrin as its active ingredient. The trade name for this product is ADEPT (4% Icodextrin) Adhesion Reduction Solution, distinguishing it from other formulations.

What regulatory pathway was followed for the approval of the ADEPT Adhesion Reduction Solution, and what product code does it fall under?

The ADEPT Adhesion Reduction Solution was approved through the FDA’s Premarket Approval (PMA) pathway under PMA number P050011. It is categorized under product code MCN, which pertains to obstetrics/gynecology applications, reflecting its intended surgical use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Baxter Healthcare Corp

Sources (1)

  • FDA PMA P050011 24 fields · synced Oct 6, 2026