510(k) K082387 ยท OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM
| Applicant | American Medical Systems, Minnetonka MN, US |
| Decision | Substantially Equivalent, Dec 4, 2008 |
| Received | Aug 19, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082387
No recall in the FDA data names this 510(k).
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