Identity
- Trade Name
- MACROPLASTIQUE IMPLANTS FDA PMA
- Generic Name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE FDA PMA
Identifiers
- PMA Number
- P040050 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
Macroplastique Implants are an injectable bulking agent designed for gastro-urology use. This medical device is indicated for transurethral injection in adult women who have been diagnosed with stress urinary incontinence primarily due to intrinsic sphincter deficiency.
This device is manufactured by Uroplasty, LLC and has received FDA premarket approval. It is intended for clinical use by medical professionals to address specific urological conditions in female patients.
Frequently asked questions
What is the primary use of Macroplastique Implants?
Macroplastique Implants are used as an injectable bulking agent for the treatment of stress urinary incontinence in adult women, specifically when the condition is caused by intrinsic sphincter deficiency.
How are Macroplastique Implants administered?
The device is administered via transurethral injection by a qualified medical professional to provide the necessary bulking effect for treating incontinence.
Who manufactures Macroplastique Implants?
Macroplastique Implants are manufactured by Uroplasty, LLC, based in Minnetonka, Minnesota.
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 | P040050 | Class III | Active |
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Manufacturer
- Manufacturer
- Uroplasty, LLC
Sources (1)
- FDA PMA P040050 24 fields · synced Sep 18, 2026