OPHIRA MINI SLING SYSTEM
May 2012
449d
Promedon S.A
1
Total
1
Cleared
0
Denied
Promedon S.A — FDA 510(k) Submissions
Promedon S.A has submitted 1 FDA 510(k) premarket notifications since 2012, of which 1 received clearance as substantially equivalent to a predicate device.
The company's most frequent device categories include Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling . Use the specialty filter in the sidebar to narrow results.
1 devices