MACROPLASTIQUE IMPLANTS
FDA premarket approval P040050 · decided 2006-10-30
Approval details
- PMA number
- P040050
- Trade name
- MACROPLASTIQUE IMPLANTS
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Uroplasty, LLC
- Date received
- 2004-12-22
- Decision date
- 2006-10-30
- Days to decision
- 677 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- APPROVAL FOR MACROPLASTIQUE IMPLANTS. THE DEVICE IS INDICATED FOR TRANSURETHRAL INJECTION IN THE TREATMENT OF ADULT WOMEN DIAGNOSED WITH STRESS URINARY INCONTINENCE (SUI) PRIMARILY DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD).
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