Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
510(k) Number K121641
Device Name MINIARC PRO SINGLE-INCISION SLING SYSTEM
Applicant
American Medical Systems
10700 Bren Rd. W
Minnetonka,  MN  55343
Applicant Contact RENEE MELLUM
Correspondent
American Medical Systems
10700 Bren Rd. W
Minnetonka,  MN  55343
Correspondent Contact RENEE MELLUM
Regulation Number878.3300
Classification Product Code
PAH  
Date Received06/04/2012
Decision Date 09/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-