Identity
- Trade Name
- COAPTITE FDA PMA
- Generic Name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE FDA PMA
Identifiers
- PMA Number
- P040047 FDA PMA
- FDA Product Code
- LNM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Gastroenterology, Urology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Coaptite Injectable Implant is a bulking agent classified as an Agent, Bulking, Injectable for Gastro-Urology Use, designed for soft tissue augmentation. It is intended to treat stress urinary incontinence (SUI) caused by intrinsic sphincter deficiency (ISD) in adult females by reinforcing the urethral support mechanism.
This device is supplied as a sterile, injectable implant and is regulated under FDA Premarket Approval (PMA P040047). Administered via urological procedures, it is intended for single-use per patient application. No MRI safety data or reusable configurations are specified, and storage conditions align with standard sterile injectable protocols.
Frequently asked questions
What is the Coaptite Injectable Implant used to treat in adult female patients?
The Coaptite Injectable Implant is specifically designed for soft tissue augmentation to treat stress urinary incontinence (SUI) caused by intrinsic sphincter deficiency (ISD) in adult females. It works by reinforcing the urethral support mechanism to help manage urinary control issues.
Is the Coaptite Injectable Implant intended for single-use or can it be reused?
The Coaptite Injectable Implant is intended for single-use per patient application. This is explicitly stated in the device’s regulatory documentation, ensuring patient safety and sterility.
How is the Coaptite Injectable Implant supplied, and what storage conditions should be followed?
The Coaptite Injectable Implant is supplied as a sterile, injectable product. Storage conditions align with standard sterile injectable protocols, meaning it should be stored according to manufacturer guidelines for sterile injectables to maintain efficacy and safety.
What regulatory pathway was followed for the approval of the Coaptite Injectable Implant?
The Coaptite Injectable Implant was approved through the FDA’s Premarket Approval (PMA) process, with the PMA number listed as P040047. This indicates a thorough review and approval by the FDA for its intended use in treating SUI due to ISD.
Are there any specific safety considerations regarding MRI use with the Coaptite Injectable Implant?
The device documentation does not specify any MRI safety data for the Coaptite Injectable Implant, meaning its safety in an MRI environment has not been evaluated or confirmed. Clinicians should exercise caution and follow best practices if MRI is required.
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
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P040047 | Class III | Active |
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Manufacturer
- Manufacturer
- Merz North America, Inc.
Sources (1)
- FDA PMA P040047 24 fields · synced Sep 18, 2026