510(k) K151437 ยท FTL Mesh, Surgical, Polymeric
ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug
| Applicant | Atrium Medical Corporation, Hudson NH, US |
| Decision | Substantially Equivalent, Aug 27, 2015 |
| Received | May 29, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151437
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 23, 2018 | Atrium Medical Corporation ProLite Mesh - mesh, surgical, polymeric
ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures re Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.