Data / Medical devices / Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling (PAH): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling (product code PAH, Class 2, 21 CFR 878.3300). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on October 18, 2024, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PAH
- Device class
- 2
- Regulation
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Ireland | 1 |
| Spain | 1 |
Makers of Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Coloplast Manufacturing Us, LLC | Minneapolis, MN, United States | Specification developer | 3 | October 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Specification developer | 1 | August 27, 2008 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 1 | August 27, 2008 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 1 | August 27, 2008 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 1 | August 27, 2008 | 0 | 0 | 0 | api.fda.gov |
| Caldera Medical, Inc. | Westlake Village, CA, United States | Manufacturer | 1 | February 7, 2020 | 0 | 0 | 0 | api.fda.gov |
| Desarrollo E Investigacion Medica Aragonesa SL | CALATAYUD Zaragoza, Spain | Manufacturer | 1 | December 19, 2006 | 0 | 0 | 0 | api.fda.gov |
| Aprios Custom Mfg. | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.